Director, Corporate Quality - GCP
for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Use - for any list of duties/requirements/benefits, and
for prose. Do NOT repeat job title as heading. Do NOT put Job ID/requisition numbers as headings. Remove boilerplate, navigation, legal, EEO, equal-opportunity, scam-warning, duplicated lines, application instructions. Include a section ONLY when posting has real, specific content for it — never emit heading followed by filler/placeholder text (e.g., "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless posting actually states them. Prefer few substantive sections over many thin ones.
We need to parse the posting.
Content:
- Intro: "Why Sarepta? Why Now? ..." includes description of company, mission, etc. Could be "About the role"? Actually "Why Sarepta? Why Now?" is more about company. Could be "About the role"? Not exactly. There's "The Importance of the Role" describing role. There's "What Sarepta Offers" describing benefits. There's "The Opportunity to Make a Difference" describing responsibilities/duties. There's "More About You" describing qualifications/requirements. There's "What Now?" describing application encouragement, hybrid work, salary range, etc. Also "The targeted salary range for this position is $185,600 - $232,000 per year." That's pay info. Also "This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time." That's schedule info (hybrid). Also "Candidates must be authorized to work in the U.S." is a requirement.
We need to decide sections: Could have About the role (maybe combine intro and role importance). Responsibilities (the "Opportunity to Make a Difference" bullet list). Requirements/Qualifications (the "More About You" list). Benefits (the "What Sarepta Offers" list). Pay (salary range). Schedule (hybrid). Possibly also "About Sarepta" but not required.
We must not create sections with filler. All sections we create must have substantive content.
We need to output only HTML fragment, no /, no markdown fences.
We need to use
for section headings. Use - for any list of duties/requirements/benefits. Use
for prose.
We must preserve all substantive information; do not invent or summarize away detail. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. The posting includes "Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify." That's EEO boilerplate; should be removed. Also "Candidates must be authorized to work in the U.S." is a requirement, keep. "This position may require up to 10% domestic and international travel." Keep as part of responsibilities or requirements? It's a requirement/travel expectation. Could be in Responsibilities or Requirements. We'll include in Responsibilities maybe.
Also "We’re always looking for solution-oriented, critical thinkers..." is fluff but still substantive? It's more about candidate traits; could be part of Requirements or Qualifications. We'll keep as part of Requirements.
Now let's extract sections.
**About the role / Company overview**: The intro "Why Sarepta? Why Now? ..." plus maybe "The Importance of the Role". Could combine into About the role. Provide prose.
**Responsibilities**: The bullet list under "The Opportunity to Make a Difference". Also maybe travel expectation.
**Requirements / Qualifications**: The list under "More About You". Also "Candidates must be authorized to work in the U.S." plus maybe "solution-oriented, critical thinkers" etc.
**Benefits**: The list under "What Sarepta Offers": Physical and Emotional Wellness, Financial Wellness, Support for Caregivers. Also mention "For a full list of our comprehensive benefits, see our website". We'll keep the three categories as list items.
**Pay**: The targeted salary range $185,600 - $232,000 per year. Also note "The salary offer is commensurate with Sarepta’s compensation philosophy..." That's filler? It's somewhat generic but still about pay. The instruction says never create Pay section unless posting actually states them. It does state salary range, so we can include Pay section with that range. The phrase "commensurate with Sarepta’s compensation philosophy..." is somewhat generic but still part of pay description; we can include as prose.
**Schedule**: Hybrid work description: "This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time." That's schedule info. Also maybe travel expectation? Travel is separate but could be part of schedule? We'll keep schedule as hybrid.
We should not create sections for filler like "commensurate with experience" etc. We have salary range, so okay.
Now we need to output HTML with headings
and appropriate content.
We need to decide which headings to use: About the role, Responsibilities, Requirements, Benefits, Pay, Schedule. Possibly also Qualifications? But we can combine Requirements and Qualifications into one section? The instruction says use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We can choose which to include. Prefer few substantive sections over many thin ones. So we could combine Requirements and Qualifications into one section called "Requirements". Or we could have separate Requirements and Qualifications if we have distinct content. The "More About You" includes education, experience, skills, etc. That's both qualifications and requirements. Could be one section.
We also have "Skills" maybe not needed.
Thus we could have sections: About the role, Responsibilities, Requirements, Benefits, Pay, Schedule.
Now we need to ensure we use - for any list of duties/requirements/benefits. For prose, use
.
We need to preserve all substantive information. Let's extract details.
**About the role** (prose):
- Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
- The Importance of the Role: The Director, Corporate Quality, will provide leadership and strategic quality oversight across Sarepta’s Clinical Development and Real-World Evidence portfolio. This role serves as a key Subject Matter Expert in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) compliance, ensuring that all clinical trial and non-clinical study activities meet FDA regulations, ICH guidelines, and applicable international standards. This role partners closely with Clinical Development, Clinical Operations, Pharmacovigilance, Non-Clinical Development & Toxicology, and Research, ensuring end-to-end regulatory compliance, scientific integrity, and patient safety.
We can combine into a couple paragraphs.
**Responsibilities** (list):
From "The Opportunity to Make a Difference":
- Provide leadership on GCP and GLP QA support and guidance to key clinical and non-clinical stakeholders, leveraging analysis and interpretation of GCP/GLP regulations to ensure best practices in Clinical, Non-clinical and QA operations.
- Act as the primary Quality business partner to R&D functional leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance areas.
- Partner with teams to resolve compliance issues identified at vendors and investigator sites; assess the impact of deficiencies and recommend corrective actions.
- Assist in the development and implementation of CAPA plans and investigations in response to quality issues, audits, and inspections.
- Review clinical trial documentation and regulatory submission materials for completeness and compliance with applicable requirements.
- Develop and maintain study-specific audit plans for assigned studies; support audit preparation, site selection, and execution, including coordination of responses.
- Contribute to the implementation and continuous improvement of GxP-compliant procedures and operations to maintain a robust Quality Management System for clinical studies.
- Support inspection readiness activities for sponsors, monitors, and sites; provide guidance and hands-on support during all GxP inspection activities.
- Perform other related duties and special projects as assigned.
Also travel expectation: "This position may require up to 10% domestic and international travel." Could be added as a list item.
**Requirements** (list):
From "More About You":
- BS/BA Degree in a scientific discipline. Advanced degree preferred.
- 12+ years of progressive experience in a related industry.
- 8+ years’ experience in Clinical Quality Assurance role, including experience with external and internal audits.
- Experience in a Non-Clinical Quality Assurance role is a strong plus.
- Demonstrated experience working with clinical trial teams.
- Extensive experience with Global Clinical trial conduct, knowledge and understanding of applicable ICH Guidelines, FDA Regulations and EU Requirements.
- Previous experience in supporting Regulatory Authority Inspections preferred.
- Previous experience in development and oversight of Quality Management Systems.
- Excellent interpersonal skills, personal integrity, professional manners and ability to gain respect and develop good working relationships with cross-functional personnel at all levels.
- This position may require up to 10% domestic and international travel. (But we already put travel in responsibilities; maybe we should not duplicate. We'll keep travel only once, maybe in Responsibilities.)
Also from "What Now?":
- We’re always looking for solution-oriented, critical thinkers. So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
- This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time. (That's schedule, not requirement.)
- The targeted salary range for this position is $185,600 - $232,000 per year. (Pay)
- Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. (Pay detail)
- Candidates must be authorized to work in the U.S. (Requirement)
- Sarepta Therapeutics offers a competitive compensation and benefit package. (Benefit generic, maybe skip as boilerplate)
- Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify. (EEO, remove)
Thus requirements list includes: BS/BA, advanced degree preferred; 12+ years progressive experience; 8+ years CQA experience; Non-Clinical QA experience a plus; demonstrated experience with clinical trial teams; extensive global clinical trial conduct knowledge; experience supporting regulatory authority inspections preferred; experience developing/overseeing QMS; excellent interpersonal skills, integrity, professional manners, ability to gain respect; solution-oriented, critical thinker, comfortable with ambiguity and candor, relish challenging yourself, place kindness and integrity at forefront; authorized to work in the U.S.
We should keep all.
**Benefits** (list):
From "What Sarepta Offers":
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Also mention "For a full list of our comprehensive
for prose. Do NOT repeat job title as heading. Do NOT put Job ID/requisition numbers as headings. Remove boilerplate, navigation, legal, EEO, equal-opportunity, scam-warning, duplicated lines, application instructions. Include a section ONLY when posting has real, specific content for it — never emit heading followed by filler/placeholder text (e.g., "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless posting actually states them. Prefer few substantive sections over many thin ones. We need to parse the posting. Content: - Intro: "Why Sarepta? Why Now? ..." includes description of company, mission, etc. Could be "About the role"? Actually "Why Sarepta? Why Now?" is more about company. Could be "About the role"? Not exactly. There's "The Importance of the Role" describing role. There's "What Sarepta Offers" describing benefits. There's "The Opportunity to Make a Difference" describing responsibilities/duties. There's "More About You" describing qualifications/requirements. There's "What Now?" describing application encouragement, hybrid work, salary range, etc. Also "The targeted salary range for this position is $185,600 - $232,000 per year." That's pay info. Also "This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time." That's schedule info (hybrid). Also "Candidates must be authorized to work in the U.S." is a requirement. We need to decide sections: Could have About the role (maybe combine intro and role importance). Responsibilities (the "Opportunity to Make a Difference" bullet list). Requirements/Qualifications (the "More About You" list). Benefits (the "What Sarepta Offers" list). Pay (salary range). Schedule (hybrid). Possibly also "About Sarepta" but not required. We must not create sections with filler. All sections we create must have substantive content. We need to output only HTML fragment, no /, no markdown fences. We need to use
for section headings. Use - for any list of duties/requirements/benefits. Use
for prose.
We must preserve all substantive information; do not invent or summarize away detail. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. The posting includes "Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify." That's EEO boilerplate; should be removed. Also "Candidates must be authorized to work in the U.S." is a requirement, keep. "This position may require up to 10% domestic and international travel." Keep as part of responsibilities or requirements? It's a requirement/travel expectation. Could be in Responsibilities or Requirements. We'll include in Responsibilities maybe.
Also "We’re always looking for solution-oriented, critical thinkers..." is fluff but still substantive? It's more about candidate traits; could be part of Requirements or Qualifications. We'll keep as part of Requirements.
Now let's extract sections.
**About the role / Company overview**: The intro "Why Sarepta? Why Now? ..." plus maybe "The Importance of the Role". Could combine into About the role. Provide prose.
**Responsibilities**: The bullet list under "The Opportunity to Make a Difference". Also maybe travel expectation.
**Requirements / Qualifications**: The list under "More About You". Also "Candidates must be authorized to work in the U.S." plus maybe "solution-oriented, critical thinkers" etc.
**Benefits**: The list under "What Sarepta Offers": Physical and Emotional Wellness, Financial Wellness, Support for Caregivers. Also mention "For a full list of our comprehensive benefits, see our website". We'll keep the three categories as list items.
**Pay**: The targeted salary range $185,600 - $232,000 per year. Also note "The salary offer is commensurate with Sarepta’s compensation philosophy..." That's filler? It's somewhat generic but still about pay. The instruction says never create Pay section unless posting actually states them. It does state salary range, so we can include Pay section with that range. The phrase "commensurate with Sarepta’s compensation philosophy..." is somewhat generic but still part of pay description; we can include as prose.
**Schedule**: Hybrid work description: "This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time." That's schedule info. Also maybe travel expectation? Travel is separate but could be part of schedule? We'll keep schedule as hybrid.
We should not create sections for filler like "commensurate with experience" etc. We have salary range, so okay.
Now we need to output HTML with headings
and appropriate content.
We need to decide which headings to use: About the role, Responsibilities, Requirements, Benefits, Pay, Schedule. Possibly also Qualifications? But we can combine Requirements and Qualifications into one section? The instruction says use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We can choose which to include. Prefer few substantive sections over many thin ones. So we could combine Requirements and Qualifications into one section called "Requirements". Or we could have separate Requirements and Qualifications if we have distinct content. The "More About You" includes education, experience, skills, etc. That's both qualifications and requirements. Could be one section.
We also have "Skills" maybe not needed.
Thus we could have sections: About the role, Responsibilities, Requirements, Benefits, Pay, Schedule.
Now we need to ensure we use - for any list of duties/requirements/benefits. For prose, use
.
We need to preserve all substantive information. Let's extract details.
**About the role** (prose):
- Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
- The Importance of the Role: The Director, Corporate Quality, will provide leadership and strategic quality oversight across Sarepta’s Clinical Development and Real-World Evidence portfolio. This role serves as a key Subject Matter Expert in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) compliance, ensuring that all clinical trial and non-clinical study activities meet FDA regulations, ICH guidelines, and applicable international standards. This role partners closely with Clinical Development, Clinical Operations, Pharmacovigilance, Non-Clinical Development & Toxicology, and Research, ensuring end-to-end regulatory compliance, scientific integrity, and patient safety.
We can combine into a couple paragraphs.
**Responsibilities** (list):
From "The Opportunity to Make a Difference":
- Provide leadership on GCP and GLP QA support and guidance to key clinical and non-clinical stakeholders, leveraging analysis and interpretation of GCP/GLP regulations to ensure best practices in Clinical, Non-clinical and QA operations.
- Act as the primary Quality business partner to R&D functional leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance areas.
- Partner with teams to resolve compliance issues identified at vendors and investigator sites; assess the impact of deficiencies and recommend corrective actions.
- Assist in the development and implementation of CAPA plans and investigations in response to quality issues, audits, and inspections.
- Review clinical trial documentation and regulatory submission materials for completeness and compliance with applicable requirements.
- Develop and maintain study-specific audit plans for assigned studies; support audit preparation, site selection, and execution, including coordination of responses.
- Contribute to the implementation and continuous improvement of GxP-compliant procedures and operations to maintain a robust Quality Management System for clinical studies.
- Support inspection readiness activities for sponsors, monitors, and sites; provide guidance and hands-on support during all GxP inspection activities.
- Perform other related duties and special projects as assigned.
Also travel expectation: "This position may require up to 10% domestic and international travel." Could be added as a list item.
**Requirements** (list):
From "More About You":
- BS/BA Degree in a scientific discipline. Advanced degree preferred.
- 12+ years of progressive experience in a related industry.
- 8+ years’ experience in Clinical Quality Assurance role, including experience with external and internal audits.
- Experience in a Non-Clinical Quality Assurance role is a strong plus.
- Demonstrated experience working with clinical trial teams.
- Extensive experience with Global Clinical trial conduct, knowledge and understanding of applicable ICH Guidelines, FDA Regulations and EU Requirements.
- Previous experience in supporting Regulatory Authority Inspections preferred.
- Previous experience in development and oversight of Quality Management Systems.
- Excellent interpersonal skills, personal integrity, professional manners and ability to gain respect and develop good working relationships with cross-functional personnel at all levels.
- This position may require up to 10% domestic and international travel. (But we already put travel in responsibilities; maybe we should not duplicate. We'll keep travel only once, maybe in Responsibilities.)
Also from "What Now?":
- We’re always looking for solution-oriented, critical thinkers. So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
- This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time. (That's schedule, not requirement.)
- The targeted salary range for this position is $185,600 - $232,000 per year. (Pay)
- Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. (Pay detail)
- Candidates must be authorized to work in the U.S. (Requirement)
- Sarepta Therapeutics offers a competitive compensation and benefit package. (Benefit generic, maybe skip as boilerplate)
- Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify. (EEO, remove)
Thus requirements list includes: BS/BA, advanced degree preferred; 12+ years progressive experience; 8+ years CQA experience; Non-Clinical QA experience a plus; demonstrated experience with clinical trial teams; extensive global clinical trial conduct knowledge; experience supporting regulatory authority inspections preferred; experience developing/overseeing QMS; excellent interpersonal skills, integrity, professional manners, ability to gain respect; solution-oriented, critical thinker, comfortable with ambiguity and candor, relish challenging yourself, place kindness and integrity at forefront; authorized to work in the U.S.
We should keep all.
**Benefits** (list):
From "What Sarepta Offers":
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Also mention "For a full list of our comprehensive
for prose. We must preserve all substantive information; do not invent or summarize away detail. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. The posting includes "Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify." That's EEO boilerplate; should be removed. Also "Candidates must be authorized to work in the U.S." is a requirement, keep. "This position may require up to 10% domestic and international travel." Keep as part of responsibilities or requirements? It's a requirement/travel expectation. Could be in Responsibilities or Requirements. We'll include in Responsibilities maybe. Also "We’re always looking for solution-oriented, critical thinkers..." is fluff but still substantive? It's more about candidate traits; could be part of Requirements or Qualifications. We'll keep as part of Requirements. Now let's extract sections. **About the role / Company overview**: The intro "Why Sarepta? Why Now? ..." plus maybe "The Importance of the Role". Could combine into About the role. Provide prose. **Responsibilities**: The bullet list under "The Opportunity to Make a Difference". Also maybe travel expectation. **Requirements / Qualifications**: The list under "More About You". Also "Candidates must be authorized to work in the U.S." plus maybe "solution-oriented, critical thinkers" etc. **Benefits**: The list under "What Sarepta Offers": Physical and Emotional Wellness, Financial Wellness, Support for Caregivers. Also mention "For a full list of our comprehensive benefits, see our website". We'll keep the three categories as list items. **Pay**: The targeted salary range $185,600 - $232,000 per year. Also note "The salary offer is commensurate with Sarepta’s compensation philosophy..." That's filler? It's somewhat generic but still about pay. The instruction says never create Pay section unless posting actually states them. It does state salary range, so we can include Pay section with that range. The phrase "commensurate with Sarepta’s compensation philosophy..." is somewhat generic but still part of pay description; we can include as prose. **Schedule**: Hybrid work description: "This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time." That's schedule info. Also maybe travel expectation? Travel is separate but could be part of schedule? We'll keep schedule as hybrid. We should not create sections for filler like "commensurate with experience" etc. We have salary range, so okay. Now we need to output HTML with headings
and appropriate content.
We need to decide which headings to use: About the role, Responsibilities, Requirements, Benefits, Pay, Schedule. Possibly also Qualifications? But we can combine Requirements and Qualifications into one section? The instruction says use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We can choose which to include. Prefer few substantive sections over many thin ones. So we could combine Requirements and Qualifications into one section called "Requirements". Or we could have separate Requirements and Qualifications if we have distinct content. The "More About You" includes education, experience, skills, etc. That's both qualifications and requirements. Could be one section.
We also have "Skills" maybe not needed.
Thus we could have sections: About the role, Responsibilities, Requirements, Benefits, Pay, Schedule.
Now we need to ensure we use - for any list of duties/requirements/benefits. For prose, use
.
We need to preserve all substantive information. Let's extract details.
**About the role** (prose):
- Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
- The Importance of the Role: The Director, Corporate Quality, will provide leadership and strategic quality oversight across Sarepta’s Clinical Development and Real-World Evidence portfolio. This role serves as a key Subject Matter Expert in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) compliance, ensuring that all clinical trial and non-clinical study activities meet FDA regulations, ICH guidelines, and applicable international standards. This role partners closely with Clinical Development, Clinical Operations, Pharmacovigilance, Non-Clinical Development & Toxicology, and Research, ensuring end-to-end regulatory compliance, scientific integrity, and patient safety.
We can combine into a couple paragraphs.
**Responsibilities** (list):
From "The Opportunity to Make a Difference":
- Provide leadership on GCP and GLP QA support and guidance to key clinical and non-clinical stakeholders, leveraging analysis and interpretation of GCP/GLP regulations to ensure best practices in Clinical, Non-clinical and QA operations.
- Act as the primary Quality business partner to R&D functional leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance areas.
- Partner with teams to resolve compliance issues identified at vendors and investigator sites; assess the impact of deficiencies and recommend corrective actions.
- Assist in the development and implementation of CAPA plans and investigations in response to quality issues, audits, and inspections.
- Review clinical trial documentation and regulatory submission materials for completeness and compliance with applicable requirements.
- Develop and maintain study-specific audit plans for assigned studies; support audit preparation, site selection, and execution, including coordination of responses.
- Contribute to the implementation and continuous improvement of GxP-compliant procedures and operations to maintain a robust Quality Management System for clinical studies.
- Support inspection readiness activities for sponsors, monitors, and sites; provide guidance and hands-on support during all GxP inspection activities.
- Perform other related duties and special projects as assigned.
Also travel expectation: "This position may require up to 10% domestic and international travel." Could be added as a list item.
**Requirements** (list):
From "More About You":
- BS/BA Degree in a scientific discipline. Advanced degree preferred.
- 12+ years of progressive experience in a related industry.
- 8+ years’ experience in Clinical Quality Assurance role, including experience with external and internal audits.
- Experience in a Non-Clinical Quality Assurance role is a strong plus.
- Demonstrated experience working with clinical trial teams.
- Extensive experience with Global Clinical trial conduct, knowledge and understanding of applicable ICH Guidelines, FDA Regulations and EU Requirements.
- Previous experience in supporting Regulatory Authority Inspections preferred.
- Previous experience in development and oversight of Quality Management Systems.
- Excellent interpersonal skills, personal integrity, professional manners and ability to gain respect and develop good working relationships with cross-functional personnel at all levels.
- This position may require up to 10% domestic and international travel. (But we already put travel in responsibilities; maybe we should not duplicate. We'll keep travel only once, maybe in Responsibilities.)
Also from "What Now?":
- We’re always looking for solution-oriented, critical thinkers. So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
- This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time. (That's schedule, not requirement.)
- The targeted salary range for this position is $185,600 - $232,000 per year. (Pay)
- Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. (Pay detail)
- Candidates must be authorized to work in the U.S. (Requirement)
- Sarepta Therapeutics offers a competitive compensation and benefit package. (Benefit generic, maybe skip as boilerplate)
- Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify. (EEO, remove)
Thus requirements list includes: BS/BA, advanced degree preferred; 12+ years progressive experience; 8+ years CQA experience; Non-Clinical QA experience a plus; demonstrated experience with clinical trial teams; extensive global clinical trial conduct knowledge; experience supporting regulatory authority inspections preferred; experience developing/overseeing QMS; excellent interpersonal skills, integrity, professional manners, ability to gain respect; solution-oriented, critical thinker, comfortable with ambiguity and candor, relish challenging yourself, place kindness and integrity at forefront; authorized to work in the U.S.
We should keep all.
**Benefits** (list):
From "What Sarepta Offers":
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Also mention "For a full list of our comprehensive
. We need to preserve all substantive information. Let's extract details. **About the role** (prose): - Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients. - The Importance of the Role: The Director, Corporate Quality, will provide leadership and strategic quality oversight across Sarepta’s Clinical Development and Real-World Evidence portfolio. This role serves as a key Subject Matter Expert in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) compliance, ensuring that all clinical trial and non-clinical study activities meet FDA regulations, ICH guidelines, and applicable international standards. This role partners closely with Clinical Development, Clinical Operations, Pharmacovigilance, Non-Clinical Development & Toxicology, and Research, ensuring end-to-end regulatory compliance, scientific integrity, and patient safety. We can combine into a couple paragraphs. **Responsibilities** (list): From "The Opportunity to Make a Difference": - Provide leadership on GCP and GLP QA support and guidance to key clinical and non-clinical stakeholders, leveraging analysis and interpretation of GCP/GLP regulations to ensure best practices in Clinical, Non-clinical and QA operations. - Act as the primary Quality business partner to R&D functional leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance areas. - Partner with teams to resolve compliance issues identified at vendors and investigator sites; assess the impact of deficiencies and recommend corrective actions. - Assist in the development and implementation of CAPA plans and investigations in response to quality issues, audits, and inspections. - Review clinical trial documentation and regulatory submission materials for completeness and compliance with applicable requirements. - Develop and maintain study-specific audit plans for assigned studies; support audit preparation, site selection, and execution, including coordination of responses. - Contribute to the implementation and continuous improvement of GxP-compliant procedures and operations to maintain a robust Quality Management System for clinical studies. - Support inspection readiness activities for sponsors, monitors, and sites; provide guidance and hands-on support during all GxP inspection activities. - Perform other related duties and special projects as assigned. Also travel expectation: "This position may require up to 10% domestic and international travel." Could be added as a list item. **Requirements** (list): From "More About You": - BS/BA Degree in a scientific discipline. Advanced degree preferred. - 12+ years of progressive experience in a related industry. - 8+ years’ experience in Clinical Quality Assurance role, including experience with external and internal audits. - Experience in a Non-Clinical Quality Assurance role is a strong plus. - Demonstrated experience working with clinical trial teams. - Extensive experience with Global Clinical trial conduct, knowledge and understanding of applicable ICH Guidelines, FDA Regulations and EU Requirements. - Previous experience in supporting Regulatory Authority Inspections preferred. - Previous experience in development and oversight of Quality Management Systems. - Excellent interpersonal skills, personal integrity, professional manners and ability to gain respect and develop good working relationships with cross-functional personnel at all levels. - This position may require up to 10% domestic and international travel. (But we already put travel in responsibilities; maybe we should not duplicate. We'll keep travel only once, maybe in Responsibilities.) Also from "What Now?": - We’re always looking for solution-oriented, critical thinkers. So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply. - This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time. (That's schedule, not requirement.) - The targeted salary range for this position is $185,600 - $232,000 per year. (Pay) - Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. (Pay detail) - Candidates must be authorized to work in the U.S. (Requirement) - Sarepta Therapeutics offers a competitive compensation and benefit package. (Benefit generic, maybe skip as boilerplate) - Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify. (EEO, remove) Thus requirements list includes: BS/BA, advanced degree preferred; 12+ years progressive experience; 8+ years CQA experience; Non-Clinical QA experience a plus; demonstrated experience with clinical trial teams; extensive global clinical trial conduct knowledge; experience supporting regulatory authority inspections preferred; experience developing/overseeing QMS; excellent interpersonal skills, integrity, professional manners, ability to gain respect; solution-oriented, critical thinker, comfortable with ambiguity and candor, relish challenging yourself, place kindness and integrity at forefront; authorized to work in the U.S. We should keep all. **Benefits** (list): From "What Sarepta Offers": - Physical and Emotional Wellness - Financial Wellness - Support for Caregivers Also mention "For a full list of our comprehensive