Executive Director, R&D Global Quality
for section headings. Use - for any list of duties/requirements/benefits. Use
for prose.
We need to decide sections: About the role (job summary paragraph). Responsibilities (Key Responsibilities). Qualifications (Qualifications/Required Knowledge/Experience and Skills). Benefits (Company benefits). Pay (Minimum $... - Maximum $...). Possibly also "Travel" could be under Responsibilities as a bullet.
We must not create sections with filler like "not specified". So only include sections with real content.
Let's extract content.
Job Summary paragraph: "We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for leading a global team focused on R&D Quality. This global role includes direct reports in the United States and dotted line reporting in Asia, Europe and North America. The leader of R&D Global Quality will ensure OAPI, OPDC and all affiliates are inspection ready, oversee clinical trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible for providing a compelling vision for the R&D Global Quality that aligns, supports and complements that of the Global Quality function. The leader shall provide guidance, strategic direction, and leadership to the Global Quality function with responsibilities for Global Clinical Quality (GCQ), CSV and GPV. In this role, the leader oversees R&D Global Quality for Otsuka and partners with the business groups and global regions to assure end-to-end Quality, harmonization of processes, and identification and mitigation of Quality risks from development through commercial registration and product distribution."
That's prose.
Key Responsibilities list: bullet points:
- Inspection Readiness: Ensure continuous inspection readiness across all clinical trial sites, clinical and Pharmacovigilance (PV) operations.
- Audit Management: Oversee the planning, execution, and follow-up of internal and external audits to ensure compliance with regulatory requirements.
- Regulatory Authority Engagement: Act as the primary liaison with regulatory authorities, facilitating Clinical and PV inspections and addressing any findings.
- Data Integrity: Ensure the accuracy, consistency, and reliability of clinical and PV data through robust Quality processes.
- Team Leadership: Lead, mentor, and develop a team of QA professionals, fostering a culture of excellence and continuous improvement.
- Stakeholder Partnership: Collaborate with key stakeholders across the organization to align QA activities with business objectives and regulatory requirements.
- Policy Development: Develops, implements, and maintains policies, systems and procedures describing internal processes for management of quality and compliance with applicable regulations and guidelines that ensure sustained GCP/QSR compliance.
- Vendor Management: Leads and develops systems for Clinical vendor management and vendor oversight.
- Management Review: Establish and maintain a system to ensure R&D Management Reviews are conducted per QSR and Company requirements.
- Budget Management: Develop and manage the departmental budgets.
Also maybe "Travel (approximately 30%)" is a separate bullet? It appears under Qualifications? Actually after Qualifications list there is "Travel (approximately 30%)". It's separate line after Qualifications list before Competencies. We'll include as a bullet under Responsibilities maybe or separate "Travel" but we don't have a heading for Travel. Could add as a bullet under Responsibilities.
Qualifications list: Let's extract:
- Bachelor’s degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment
- Strong knowledge of current global Good Clinical Practice (GCP) for designing, recording and reporting trials that involve the participation of human subjects. Managing compliance with this standard to provide assurance that the rights, safety and wellbeing of trial subjects are protected, and that clinical-trial data are credible.
- Current and in-depth knowledge of audit techniques and government regulatory inspection procedures
- Strong engagement with the OPCJ business will be required warranting a requirement for experience and successful interaction within a Japanese company, or a multi-national with a Japanese arm.
- Previous experience of working in the global pharmaceutical and medical device industry.
- Experience working with external service providers.
- Working knowledge of current Good Manufacturing Practice (cGMP) regulations.
- Strong project management, leadership, problem solving, and organization skills.
- High level of emotional intelligence.
- Exceptional leadership and team development skills.
- Excellent communication and interpersonal skills.
- Ability to work collaboratively with cross-functional teams.
- Strategic thinking and problem-solving abilities.
- Travel (approximately 30%) (maybe include here)
- Competencies list: but those are competencies, maybe we can include under Qualifications as bullet points? They are more like competencies. Could include as bullet list under Qualifications or separate "Competencies" section. The instruction: use headings only when posting has real specific content. Competencies are present. Could make a section "Competencies". But we need to decide if we want many thin sections vs few substantive. The instruction: Prefer a few substantive sections over many thin ones. So maybe we incorporate competencies into Qualifications or Responsibilities. However they are distinct. Could create a section "Competencies" but that might be thin? It has several bullet points. Might be okay. But we already have Qualifications, Responsibilities, Benefits, Pay. Adding Competencies makes 5 sections. Might be okay.
But we need to avoid filler like "commensurate with experience". Not present.
Let's extract Competencies bullet points:
- Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
- Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
- Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
- Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
- Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
- Empowered Development - Play an active role in professional development as a business imperative.
We'll include as
- .
Benefits: "Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits."
We can turn into list.
Pay: "Minimum $249,973.00 - Maximum $388,125.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws."
We need to output as prose
. Not create heading if content is just that? We'll create Pay section heading
Pay
and then with that text.
Schedule: Not present, so omit.
Now ensure we don't include boilerplate like "Application Deadline:", "Company benefits:" we already used but we need to strip the label "Company benefits:" maybe keep as part of prose? We'll just list benefits.
We must not include links. So remove the URLs.
Now produce HTML fragment.
Structure:
About the Role
Job summary paragraph.
Responsibilities
- ...
...
Qualifications
- ...
...
Competencies
- ...
...
Benefits
- ...
...
Pay
Pay range text.
Check for any duplicated lines: ensure we didn't repeat.
Now craft the content precisely.
About the Role paragraph: Use the job summary exactly as given but maybe we can keep as is.
Let's copy:
We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for leading a global team focused on R&D Quality. This global role includes direct reports in the United States and dotted line reporting in Asia, Europe and North America. The leader of R&D Global Quality will ensure OAPI, OPDC and all affiliates are inspection ready, oversee clinical trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible for providing a compelling vision for the R&D Global Quality that aligns, supports and complements that of the Global Quality function. The leader shall provide guidance, strategic direction, and leadership to the Global Quality function with responsibilities for Global Clinical Quality (GCQ), CSV and GPV. In this role, the leader oversees R&D Global Quality for Otsuka and partners with the business groups and global regions to assure end-to-end Quality, harmonization of processes, and identification and mitigation of Quality risks from development through commercial registration and product distribution.
Now Responsibilities bullets: Ensure each bullet starts with the heading (like Inspection Readiness: ...) as given.
List:
- Inspection Readiness: Ensure continuous inspection readiness across all clinical trial sites, clinical and Pharmacovigilance (PV) operations.
- Audit Management: Oversee the planning, execution, and follow-up of internal and external audits to ensure compliance with regulatory requirements.
- Regulatory Authority Engagement: Act as the primary liaison with regulatory authorities, facilitating Clinical and PV inspections and addressing any findings.
- Data Integrity: Ensure the accuracy, consistency, and reliability of clinical and PV data through robust Quality processes.
- Team Leadership: Lead, mentor, and develop a team of QA professionals, fostering a culture of excellence and continuous improvement.
- Stakeholder Partnership: Collaborate with key stakeholders across the organization to align QA activities with business objectives and regulatory requirements.
- Policy Development: Develops, implements, and maintains policies, systems and procedures describing internal processes for management of quality and compliance with applicable regulations and guidelines that ensure sustained GCP/QSR compliance.
- Vendor Management: Leads and develops systems for Clinical vendor management and vendor oversight.
- Management Review: Establish and maintain a system to ensure R&D Management Reviews are conducted per QSR and Company requirements.
- Budget Management: Develop and manage the departmental budgets.
- Travel: Approximately 30% travel required.
We added Travel bullet.
Now Qualifications bullets: Need to capture each item.
List:
- Bachelor’s degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment
- Strong knowledge of current global Good Clinical Practice (G
for prose. We need to decide sections: About the role (job summary paragraph). Responsibilities (Key Responsibilities). Qualifications (Qualifications/Required Knowledge/Experience and Skills). Benefits (Company benefits). Pay (Minimum $... - Maximum $...). Possibly also "Travel" could be under Responsibilities as a bullet. We must not create sections with filler like "not specified". So only include sections with real content. Let's extract content. Job Summary paragraph: "We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for leading a global team focused on R&D Quality. This global role includes direct reports in the United States and dotted line reporting in Asia, Europe and North America. The leader of R&D Global Quality will ensure OAPI, OPDC and all affiliates are inspection ready, oversee clinical trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible for providing a compelling vision for the R&D Global Quality that aligns, supports and complements that of the Global Quality function. The leader shall provide guidance, strategic direction, and leadership to the Global Quality function with responsibilities for Global Clinical Quality (GCQ), CSV and GPV. In this role, the leader oversees R&D Global Quality for Otsuka and partners with the business groups and global regions to assure end-to-end Quality, harmonization of processes, and identification and mitigation of Quality risks from development through commercial registration and product distribution." That's prose. Key Responsibilities list: bullet points: - Inspection Readiness: Ensure continuous inspection readiness across all clinical trial sites, clinical and Pharmacovigilance (PV) operations. - Audit Management: Oversee the planning, execution, and follow-up of internal and external audits to ensure compliance with regulatory requirements. - Regulatory Authority Engagement: Act as the primary liaison with regulatory authorities, facilitating Clinical and PV inspections and addressing any findings. - Data Integrity: Ensure the accuracy, consistency, and reliability of clinical and PV data through robust Quality processes. - Team Leadership: Lead, mentor, and develop a team of QA professionals, fostering a culture of excellence and continuous improvement. - Stakeholder Partnership: Collaborate with key stakeholders across the organization to align QA activities with business objectives and regulatory requirements. - Policy Development: Develops, implements, and maintains policies, systems and procedures describing internal processes for management of quality and compliance with applicable regulations and guidelines that ensure sustained GCP/QSR compliance. - Vendor Management: Leads and develops systems for Clinical vendor management and vendor oversight. - Management Review: Establish and maintain a system to ensure R&D Management Reviews are conducted per QSR and Company requirements. - Budget Management: Develop and manage the departmental budgets. Also maybe "Travel (approximately 30%)" is a separate bullet? It appears under Qualifications? Actually after Qualifications list there is "Travel (approximately 30%)". It's separate line after Qualifications list before Competencies. We'll include as a bullet under Responsibilities maybe or separate "Travel" but we don't have a heading for Travel. Could add as a bullet under Responsibilities. Qualifications list: Let's extract: - Bachelor’s degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment - Strong knowledge of current global Good Clinical Practice (GCP) for designing, recording and reporting trials that involve the participation of human subjects. Managing compliance with this standard to provide assurance that the rights, safety and wellbeing of trial subjects are protected, and that clinical-trial data are credible. - Current and in-depth knowledge of audit techniques and government regulatory inspection procedures - Strong engagement with the OPCJ business will be required warranting a requirement for experience and successful interaction within a Japanese company, or a multi-national with a Japanese arm. - Previous experience of working in the global pharmaceutical and medical device industry. - Experience working with external service providers. - Working knowledge of current Good Manufacturing Practice (cGMP) regulations. - Strong project management, leadership, problem solving, and organization skills. - High level of emotional intelligence. - Exceptional leadership and team development skills. - Excellent communication and interpersonal skills. - Ability to work collaboratively with cross-functional teams. - Strategic thinking and problem-solving abilities. - Travel (approximately 30%) (maybe include here) - Competencies list: but those are competencies, maybe we can include under Qualifications as bullet points? They are more like competencies. Could include as bullet list under Qualifications or separate "Competencies" section. The instruction: use headings only when posting has real specific content. Competencies are present. Could make a section "Competencies". But we need to decide if we want many thin sections vs few substantive. The instruction: Prefer a few substantive sections over many thin ones. So maybe we incorporate competencies into Qualifications or Responsibilities. However they are distinct. Could create a section "Competencies" but that might be thin? It has several bullet points. Might be okay. But we already have Qualifications, Responsibilities, Benefits, Pay. Adding Competencies makes 5 sections. Might be okay. But we need to avoid filler like "commensurate with experience". Not present. Let's extract Competencies bullet points: - Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. - Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business. - Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders. - Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. - Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals. - Empowered Development - Play an active role in professional development as a business imperative. We'll include as
- .
Benefits: "Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits."
We can turn into list.
Pay: "Minimum $249,973.00 - Maximum $388,125.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws."
We need to output as prose
. Not create heading if content is just that? We'll create Pay section heading
Pay
and thenwith that text. Schedule: Not present, so omit. Now ensure we don't include boilerplate like "Application Deadline:", "Company benefits:" we already used but we need to strip the label "Company benefits:" maybe keep as part of prose? We'll just list benefits. We must not include links. So remove the URLs. Now produce HTML fragment. Structure:
About the Role
Job summary paragraph.
Responsibilities
- ... ...
Qualifications
- ... ...
Competencies
- ... ...
Benefits
- ... ...
Pay
Pay range text.
Check for any duplicated lines: ensure we didn't repeat. Now craft the content precisely. About the Role paragraph: Use the job summary exactly as given but maybe we can keep as is. Let's copy: We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for leading a global team focused on R&D Quality. This global role includes direct reports in the United States and dotted line reporting in Asia, Europe and North America. The leader of R&D Global Quality will ensure OAPI, OPDC and all affiliates are inspection ready, oversee clinical trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible for providing a compelling vision for the R&D Global Quality that aligns, supports and complements that of the Global Quality function. The leader shall provide guidance, strategic direction, and leadership to the Global Quality function with responsibilities for Global Clinical Quality (GCQ), CSV and GPV. In this role, the leader oversees R&D Global Quality for Otsuka and partners with the business groups and global regions to assure end-to-end Quality, harmonization of processes, and identification and mitigation of Quality risks from development through commercial registration and product distribution. Now Responsibilities bullets: Ensure each bullet starts with the heading (like Inspection Readiness: ...) as given. List: - Inspection Readiness: Ensure continuous inspection readiness across all clinical trial sites, clinical and Pharmacovigilance (PV) operations. - Audit Management: Oversee the planning, execution, and follow-up of internal and external audits to ensure compliance with regulatory requirements. - Regulatory Authority Engagement: Act as the primary liaison with regulatory authorities, facilitating Clinical and PV inspections and addressing any findings. - Data Integrity: Ensure the accuracy, consistency, and reliability of clinical and PV data through robust Quality processes. - Team Leadership: Lead, mentor, and develop a team of QA professionals, fostering a culture of excellence and continuous improvement. - Stakeholder Partnership: Collaborate with key stakeholders across the organization to align QA activities with business objectives and regulatory requirements. - Policy Development: Develops, implements, and maintains policies, systems and procedures describing internal processes for management of quality and compliance with applicable regulations and guidelines that ensure sustained GCP/QSR compliance. - Vendor Management: Leads and develops systems for Clinical vendor management and vendor oversight. - Management Review: Establish and maintain a system to ensure R&D Management Reviews are conducted per QSR and Company requirements. - Budget Management: Develop and manage the departmental budgets. - Travel: Approximately 30% travel required. We added Travel bullet. Now Qualifications bullets: Need to capture each item. List: - Bachelor’s degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment - Strong knowledge of current global Good Clinical Practice (G