Director, Quality Assurance (GMP Operations)
Gilead Sciences · San Francisco Bay Area · 1 mo ago
Quality Assurance$210k–$272k/yrFull-time
We need to output HTML fragment with sections: About the role? Actually the posting includes description paragraphs. We need to use for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections when posting has real specific content. We have:
- About the role: The description includes mission, role description. Could be "About the role" section.
- Responsibilities: The "Key Responsibilities" section with bullet points.
- Requirements: The "Specific Education & Experience Requirements" section.
- Qualifications: Could be "Qualifications" maybe overlapping with requirements? The posting includes "Knowledge" list (knowledge, certifications). That could be "Qualifications" or "Skills". We need to decide.
- Skills: The knowledge list includes many skills; could be placed under Skills.
- Benefits: The posting mentions benefits: "paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*". Also discretionary annual bonus, stock-based long-term incentives. So we have benefits content.
- Pay: Salary range given: $210,375.00 - $272,250.00. Also mention discretionary bonus etc. So Pay section.
- Schedule: Not mentioned. No schedule info. So we should not include Schedule section.
We must not repeat job title as heading. No Job ID.
We must remove boilerplate: EEO, legal, accommodation, etc. Also remove "For Additional Benefits Information, Visit ..."? That's part of benefits but maybe keep as link? It's okay to keep but it's a URL. It's not boilerplate? It's a link to benefits info; could keep. However we should remove "For Jobs In The United States ..." and all EEO statements. Also remove "NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ..." etc. Also remove "For Current Gilead Employees And Contractors Please apply via the Internal Career Opportunities portal in Workday." That's application instruction; remove.
We must preserve all substantive information. So we need to include the mission paragraphs, role description, responsibilities bullet list, requirements bullet list, knowledge/skills list, benefits, pay.
We need to format using
for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections when posting has real specific content. We have:
- About the role: The description includes mission, role description. Could be "About the role" section.
- Responsibilities: The "Key Responsibilities" section with bullet points.
- Requirements: The "Specific Education & Experience Requirements" section.
- Qualifications: Could be "Qualifications" maybe overlapping with requirements? The posting includes "Knowledge" list (knowledge, certifications). That could be "Qualifications" or "Skills". We need to decide.
- Skills: The knowledge list includes many skills; could be placed under Skills.
- Benefits: The posting mentions benefits: "paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*". Also discretionary annual bonus, stock-based long-term incentives. So we have benefits content.
- Pay: Salary range given: $210,375.00 - $272,250.00. Also mention discretionary bonus etc. So Pay section.
- Schedule: Not mentioned. No schedule info. So we should not include Schedule section.
We must not repeat job title as heading. No Job ID.
We must remove boilerplate: EEO, legal, accommodation, etc. Also remove "For Additional Benefits Information, Visit ..."? That's part of benefits but maybe keep as link? It's okay to keep but it's a URL. It's not boilerplate? It's a link to benefits info; could keep. However we should remove "For Jobs In The United States ..." and all EEO statements. Also remove "NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ..." etc. Also remove "For Current Gilead Employees And Contractors Please apply via the Internal Career Opportunities portal in Workday." That's application instruction; remove.
We must preserve all substantive information. So we need to include the mission paragraphs, role description, responsibilities bullet list, requirements bullet list, knowledge/skills list, benefits, pay.
We need to format using headings, - for lists,
for prose.
We need to decide which content goes where.
Potential sections:
About the role
At Gilead, we’re creating a healthier world for all people.... The Director, Quality Assurance – GMP Operations provides senior Quality leadership and direct quality oversight of Manufacturing and Quality Control (QC) at the Foster City site.... This is a site-based role at our facility in Foster City, CA.
That captures the introductory paragraphs and role description.
Responsibilities
- Provide Quality Assurance oversight of GMP Manufacturing and QC testing operations through the product lifecycle from master cell bank to drug product.
- Provide Quality Assurance strategy and oversight of external QC laboratories, ensuring method lifecycle activities (qualification, verification, and validation) are executed in compliance with cGMP, ICH, and internal quality standards, with appropriate review and approval of protocols, reports, and methods.
- Review and approve laboratory investigations (e.g., OOS/OOT/deviations) conducted by contract partners, ensuring thorough root cause analysis, robust corrective and preventive actions (CAPA), and aligned decision-making impacting product quality and disposition.
- Apply Quality Risk Management principles to oversee risk assessments in collaboration with Manufacturing, and QC operations.
- Partner with cross-functional teams to identify, assess, and mitigate quality risks impacting product quality, patient safety, and supply continuity.
- Ensure quality risk decisions are appropriately justified, documented, and aligned with internal procedures and regulatory expectations.
- Partner with Manufacturing operations and QC to resolve quality issues arising during manufacturing, laboratory activities and material receipt and shipping.
- Oversee implementation and manufacturing workflow development for the startup of digital manufacturing and data solutions in collaboration with manufacturing, automation, engineering, and information technology teams.
- Review and approve manufacturing and test records, deviations, investigations, change controls, and CAPA to ensure product quality and support timely product disposition.
- Evaluate operational and quality risks related to new product introduction.
- Participate in internal GMP audits and routine walk-throughs of Manufacturing, QC, and Warehouse areas to support continuous improvement.
- Serve as a key Quality contact during regulatory inspections and internal audits, including preparation and response to findings.
- Monitor regulatory requirements and proactively assess potential operational compliance risks.
- Approve GMP documentation including risk assessments, procedures, master batch records, specifications, and analytical methods.
- Drive continuous improvement of quality processes supporting GMP operations.
- Provide leadership, development, and mentoring for Quality personnel supporting GMP operations.
- Partner cross-functionally with Manufacturing, QC, Process Development, Engineering, Supply Chain, and Quality management on corporate and site initiatives.
- Lead or support Quality-related operational projects and improvement initiatives.
- Provide on-call Quality Assurance support to Manufacturing and QC operations, as required.
- Use risk-based decision making to prioritize tasks and ensure product quality.
- Maintain strong working knowledge of Health Canada, FDA, and global GMP expectations.
That seems comprehensive.
Requirements
- 12+ years of relevant experience in a GMP environment related field and a Bachelor’s degree in science or related field OR
- 10+ years of relevant experience and a MS OR
- 8+ years of relevant experience and a PharmD/PhD
- Extensive hands-on experience supporting biologics, GMP Manufacturing and QC operations is required.
- Proven experience leading investigations, CAPA, and change management in a GMP operational environment is required.
- Strong understanding and experience of materials management, manufacturing and analytical methods and testing systems within a GMP environment.
- Previous experience in people management within Quality is required.
- Strong cross-functional collaboration and communication skills are required.
Qualifications
Maybe we can put knowledge list under Qualifications or Skills. The knowledge list includes: Demonstrates in-depth knowledge of GMPs and/or GLPs; QA principles; Computer Systems Validation and ICH Guidelines; excellent verbal, written and interpersonal communication skills; knowledge of Six Sigma DMAIC; performance measures and quality improvement statistical; working knowledge of Risk Management tools (HACCP and/or FMEA); Certification by ASQ (CQA, CQE, CQM) or other industry-recognized professional organizations.
We could put that under Qualifications.
Skills
Maybe we could separate: The knowledge list could be Skills. But we already used Qualifications for knowledge; maybe better to put knowledge under Skills and keep Qualifications for certifications? However the posting says "Knowledge Demonstrates ..." then "Certification by ASQ...". So we could have Skills for the knowledge items, and Qualifications for certification and experience? But we already used Requirements for experience/education. So Qualifications could be for certifications. Let's decide:
- Requirements: education/experience.
- Qualifications: certifications (ASQ) and maybe also the knowledge? But knowledge is more like skills.
Better: Use Skills for the knowledge list (knowledge of GMP, QA principles, CSV, ICH, communication, Six Sigma, risk management). Use Qualifications for certifications (ASQ). However the posting also mentions "Demonstrates excellent verbal, written and interpersonal communication skills." That's a skill.
Thus:
Skills
- In-depth knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
- In-depth knowledge of QA principles, concepts, industry practices, and standards.
- Keen understanding of Computer Systems Validation and ICH Guidelines.
- Excellent verbal, written and interpersonal communication skills.
- Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical.
- Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and/or Failure Mode Effects Analysis (FMEA)).
Qualifications
- Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations.
But we might also include "People Leader Accountabilities" as part of Responsibilities? It's a separate section about leadership expectations. Could be part of Responsibilities or maybe a separate section like "Leadership Expectations". But we only have allowed headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can fold People Leader Accountabilities into Responsibilities (as they are responsibilities of a people leader). We can add bullet points under Responsibilities for those.
Let's add bullet points:
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
We'll add those under Responsibilities.
Now Benefits section: The posting says: "This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For Additional Benefits Information, Visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans."
We should keep the benefits description, maybe as a and a
for list of benefits? The benefits include medical, dental, vision, life insurance. Also discretionary annual bonus, stock-based long-term incentives, paid time off. We'll put as .
Pay section: Salary range: $210,375.00 - $272,250.00. Also mention that actual compensation will vary based on experience, qualifications, geographic location. Also mention discretionary annual bonus, stock-based long-term incentives. We'll put that in .
Schedule: Not present, so omit.
Now we need to ensure we don't include any boilerplate like EEO, legal, accommodation, etc. Also remove "For Additional Benefits Information, Visit ..."? That's a link; we could keep as part of benefits but it's not boilerplate; it's a URL for more info. Might be okay to keep as part of benefits paragraph. However the instruction: "Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions." The link is not boilerplate; it's a reference for benefits info. I'd keep it.
Now produce HTML fragment.
Let's craft:
About the role
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and
- for lists,
for prose. We need to decide which content goes where. Potential sections:
About the role
At Gilead, we’re creating a healthier world for all people.... The Director, Quality Assurance – GMP Operations provides senior Quality leadership and direct quality oversight of Manufacturing and Quality Control (QC) at the Foster City site.... This is a site-based role at our facility in Foster City, CA.
That captures the introductory paragraphs and role description.Responsibilities
- Provide Quality Assurance oversight of GMP Manufacturing and QC testing operations through the product lifecycle from master cell bank to drug product.
- Provide Quality Assurance strategy and oversight of external QC laboratories, ensuring method lifecycle activities (qualification, verification, and validation) are executed in compliance with cGMP, ICH, and internal quality standards, with appropriate review and approval of protocols, reports, and methods.
- Review and approve laboratory investigations (e.g., OOS/OOT/deviations) conducted by contract partners, ensuring thorough root cause analysis, robust corrective and preventive actions (CAPA), and aligned decision-making impacting product quality and disposition.
- Apply Quality Risk Management principles to oversee risk assessments in collaboration with Manufacturing, and QC operations.
- Partner with cross-functional teams to identify, assess, and mitigate quality risks impacting product quality, patient safety, and supply continuity.
- Ensure quality risk decisions are appropriately justified, documented, and aligned with internal procedures and regulatory expectations.
- Partner with Manufacturing operations and QC to resolve quality issues arising during manufacturing, laboratory activities and material receipt and shipping.
- Oversee implementation and manufacturing workflow development for the startup of digital manufacturing and data solutions in collaboration with manufacturing, automation, engineering, and information technology teams.
- Review and approve manufacturing and test records, deviations, investigations, change controls, and CAPA to ensure product quality and support timely product disposition.
- Evaluate operational and quality risks related to new product introduction.
- Participate in internal GMP audits and routine walk-throughs of Manufacturing, QC, and Warehouse areas to support continuous improvement.
- Serve as a key Quality contact during regulatory inspections and internal audits, including preparation and response to findings.
- Monitor regulatory requirements and proactively assess potential operational compliance risks.
- Approve GMP documentation including risk assessments, procedures, master batch records, specifications, and analytical methods.
- Drive continuous improvement of quality processes supporting GMP operations.
- Provide leadership, development, and mentoring for Quality personnel supporting GMP operations.
- Partner cross-functionally with Manufacturing, QC, Process Development, Engineering, Supply Chain, and Quality management on corporate and site initiatives.
- Lead or support Quality-related operational projects and improvement initiatives.
- Provide on-call Quality Assurance support to Manufacturing and QC operations, as required.
- Use risk-based decision making to prioritize tasks and ensure product quality.
- Maintain strong working knowledge of Health Canada, FDA, and global GMP expectations.
Requirements
- 12+ years of relevant experience in a GMP environment related field and a Bachelor’s degree in science or related field OR
- 10+ years of relevant experience and a MS OR
- 8+ years of relevant experience and a PharmD/PhD
- Extensive hands-on experience supporting biologics, GMP Manufacturing and QC operations is required.
- Proven experience leading investigations, CAPA, and change management in a GMP operational environment is required.
- Strong understanding and experience of materials management, manufacturing and analytical methods and testing systems within a GMP environment.
- Previous experience in people management within Quality is required.
- Strong cross-functional collaboration and communication skills are required.
Qualifications
Maybe we can put knowledge list under Qualifications or Skills. The knowledge list includes: Demonstrates in-depth knowledge of GMPs and/or GLPs; QA principles; Computer Systems Validation and ICH Guidelines; excellent verbal, written and interpersonal communication skills; knowledge of Six Sigma DMAIC; performance measures and quality improvement statistical; working knowledge of Risk Management tools (HACCP and/or FMEA); Certification by ASQ (CQA, CQE, CQM) or other industry-recognized professional organizations. We could put that under Qualifications.Skills
Maybe we could separate: The knowledge list could be Skills. But we already used Qualifications for knowledge; maybe better to put knowledge under Skills and keep Qualifications for certifications? However the posting says "Knowledge Demonstrates ..." then "Certification by ASQ...". So we could have Skills for the knowledge items, and Qualifications for certification and experience? But we already used Requirements for experience/education. So Qualifications could be for certifications. Let's decide: - Requirements: education/experience. - Qualifications: certifications (ASQ) and maybe also the knowledge? But knowledge is more like skills. Better: Use Skills for the knowledge list (knowledge of GMP, QA principles, CSV, ICH, communication, Six Sigma, risk management). Use Qualifications for certifications (ASQ). However the posting also mentions "Demonstrates excellent verbal, written and interpersonal communication skills." That's a skill. Thus:Skills
- In-depth knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
- In-depth knowledge of QA principles, concepts, industry practices, and standards.
- Keen understanding of Computer Systems Validation and ICH Guidelines.
- Excellent verbal, written and interpersonal communication skills.
- Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical.
- Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and/or Failure Mode Effects Analysis (FMEA)).
Qualifications
- Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations.
and a
- for list of benefits? The benefits include medical, dental, vision, life insurance. Also discretionary annual bonus, stock-based long-term incentives, paid time off. We'll put as
- .
Pay section: Salary range: $210,375.00 - $272,250.00. Also mention that actual compensation will vary based on experience, qualifications, geographic location. Also mention discretionary annual bonus, stock-based long-term incentives. We'll put that in
. Schedule: Not present, so omit. Now we need to ensure we don't include any boilerplate like EEO, legal, accommodation, etc. Also remove "For Additional Benefits Information, Visit ..."? That's a link; we could keep as part of benefits but it's not boilerplate; it's a URL for more info. Might be okay to keep as part of benefits paragraph. However the instruction: "Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions." The link is not boilerplate; it's a reference for benefits info. I'd keep it. Now produce HTML fragment. Let's craft:
About the role
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and