Gilead Sciences
Senior Director, Global Supplier Quality
Gilead Sciences, San Francisco, California, United States, 94199
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.
Join Gilead and help create possible, together.
Job Summary
Lead a team of 10–15 Quality Professionals to define, lead and manage the Global Supplier Quality program by providing quality oversight of GMP material and commodity suppliers.
Collaborate with internal and external networks to continually improve Gilead’s Global Supplier Quality program, from selection, onboarding, qualification, and routine quality and performance oversight of global and local GMP material and commodity suppliers.
Demonstrate leadership skills and extensive working knowledge of managing GMP material and commodity suppliers’ performance and relationships.
Manage a matrix organization comprising Supplier Quality members from each of Gilead’s sites.
Apply technical understanding of different material categories supporting GMP manufacturing of Gilead product modalities.
Influence Gilead’s external network on selection of GMP material and commodity suppliers in alignment with Gilead’s standards.
Maintain familiarity with applicable regulations and requirements relating to GMP material and commodity supplier management and the clear delineation of responsibilities between marketing authorization holders and contract manufacturing organizations.
Communicate, influence and negotiate to evaluate options and trade‑offs and utilize resources to achieve the most positive business impact; partner with leaders in PDM functions (Technical Development, Packaging Development, Engineering, Global Manufacturing, Procurement, Regulatory CMC, and Site Quality) to achieve objectives.
Possess a proven track record in leading Global Supplier Quality programs in other global biotech or pharmaceutical companies, preferably with established relationships with reputable GMP material and commodity suppliers.
Job Functions
Execute an integrated and sustainable Global Supplier Quality strategy for Gilead’s clinical and commercial products.
Develop processes to communicate lessons learned and drive supplier quality improvement initiatives.
Create a process for exchanging lessons learned across multiple company representatives and identify opportunities for Gilead’s process improvements.
Collaborate with Technical and Quality leadership to identify solutions and processes and align with key partners on implementation of new requirements.
Implement continuous improvement initiatives to drive the Global Supplier Quality program and ensure maximum productivity.
Develop, implement, and monitor Global Supplier Quality program, policies, and procedures to ensure compliance with GxP standards, corporate policies, FDA, EMA, and other regulatory bodies.
Set and drive compliance to department, site and global KPIs.
Evaluate current Global Supplier Quality systems and processes and recommend and implement appropriate enhancements and training.
Engage and represent professional organizations; benchmark in industry networks.
Provide guidance on technical regulatory requirements and lead assistance where needed.
Participate in internal business and technical forums as Quality’s voice for GMP material and commodity supplier oversight.
Conduct regular review and assessment of regulatory intelligence and communicate concerns, trends, gaps, and alerts to Quality management promptly.
Think and act globally to anticipate potential problems and risks related to regulatory compliance expectations.
Approximately 20% travel is expected.
Knowledge, Experience and Skills
Expert in quality requirements pertaining to GMP material and commodity supplier management with strong emphasis on quality and performance management, including risk identification and mitigation.
In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally.
Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles.
In-depth knowledge of global requirements and standards for GMP material and commodity supplier life‑cycle management.
Ability to develop solutions to complex problems requiring ingenuity, creativity, and innovation where precedent may not exist.
Excellent verbal, written, and interpersonal communication skills.
Ability to interact with regulatory agencies and represent Gilead in public forums.
Experience managing a team of highly technical staff.
Expertise in managing resources to address competing projects and timelines.
Basic Qualifications
12–15 years of relevant experience and a bachelor’s degree in science or related fields; or 8+ years of relevant experience and an advanced science degree (MS, MD, PharmD, PhD) or an advanced business degree (MBA).
Prior leadership experience in a complex organization is required.
Expert knowledge in technical and regulatory requirements for GMP material and commodity supplier management is required.
Biopharmaceutical or pharmaceutical experience is required.
Prior experience leading Global or Local Supplier Quality organizations in a global biotech or pharmaceutical company is required.
Experience with GMP material and commodity category management covering different Gilead product modalities is preferred.
The salary range for this position is: $243,100.00 – $314,600.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans*.
Benefits Information For additional benefits information, visit
https://www.gilead.com/careers/compensation-benefits-and-wellbeing .
Equal Employment Opportunity Statement Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
#J-18808-Ljbffr
Join Gilead and help create possible, together.
Job Summary
Lead a team of 10–15 Quality Professionals to define, lead and manage the Global Supplier Quality program by providing quality oversight of GMP material and commodity suppliers.
Collaborate with internal and external networks to continually improve Gilead’s Global Supplier Quality program, from selection, onboarding, qualification, and routine quality and performance oversight of global and local GMP material and commodity suppliers.
Demonstrate leadership skills and extensive working knowledge of managing GMP material and commodity suppliers’ performance and relationships.
Manage a matrix organization comprising Supplier Quality members from each of Gilead’s sites.
Apply technical understanding of different material categories supporting GMP manufacturing of Gilead product modalities.
Influence Gilead’s external network on selection of GMP material and commodity suppliers in alignment with Gilead’s standards.
Maintain familiarity with applicable regulations and requirements relating to GMP material and commodity supplier management and the clear delineation of responsibilities between marketing authorization holders and contract manufacturing organizations.
Communicate, influence and negotiate to evaluate options and trade‑offs and utilize resources to achieve the most positive business impact; partner with leaders in PDM functions (Technical Development, Packaging Development, Engineering, Global Manufacturing, Procurement, Regulatory CMC, and Site Quality) to achieve objectives.
Possess a proven track record in leading Global Supplier Quality programs in other global biotech or pharmaceutical companies, preferably with established relationships with reputable GMP material and commodity suppliers.
Job Functions
Execute an integrated and sustainable Global Supplier Quality strategy for Gilead’s clinical and commercial products.
Develop processes to communicate lessons learned and drive supplier quality improvement initiatives.
Create a process for exchanging lessons learned across multiple company representatives and identify opportunities for Gilead’s process improvements.
Collaborate with Technical and Quality leadership to identify solutions and processes and align with key partners on implementation of new requirements.
Implement continuous improvement initiatives to drive the Global Supplier Quality program and ensure maximum productivity.
Develop, implement, and monitor Global Supplier Quality program, policies, and procedures to ensure compliance with GxP standards, corporate policies, FDA, EMA, and other regulatory bodies.
Set and drive compliance to department, site and global KPIs.
Evaluate current Global Supplier Quality systems and processes and recommend and implement appropriate enhancements and training.
Engage and represent professional organizations; benchmark in industry networks.
Provide guidance on technical regulatory requirements and lead assistance where needed.
Participate in internal business and technical forums as Quality’s voice for GMP material and commodity supplier oversight.
Conduct regular review and assessment of regulatory intelligence and communicate concerns, trends, gaps, and alerts to Quality management promptly.
Think and act globally to anticipate potential problems and risks related to regulatory compliance expectations.
Approximately 20% travel is expected.
Knowledge, Experience and Skills
Expert in quality requirements pertaining to GMP material and commodity supplier management with strong emphasis on quality and performance management, including risk identification and mitigation.
In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally.
Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles.
In-depth knowledge of global requirements and standards for GMP material and commodity supplier life‑cycle management.
Ability to develop solutions to complex problems requiring ingenuity, creativity, and innovation where precedent may not exist.
Excellent verbal, written, and interpersonal communication skills.
Ability to interact with regulatory agencies and represent Gilead in public forums.
Experience managing a team of highly technical staff.
Expertise in managing resources to address competing projects and timelines.
Basic Qualifications
12–15 years of relevant experience and a bachelor’s degree in science or related fields; or 8+ years of relevant experience and an advanced science degree (MS, MD, PharmD, PhD) or an advanced business degree (MBA).
Prior leadership experience in a complex organization is required.
Expert knowledge in technical and regulatory requirements for GMP material and commodity supplier management is required.
Biopharmaceutical or pharmaceutical experience is required.
Prior experience leading Global or Local Supplier Quality organizations in a global biotech or pharmaceutical company is required.
Experience with GMP material and commodity category management covering different Gilead product modalities is preferred.
The salary range for this position is: $243,100.00 – $314,600.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans*.
Benefits Information For additional benefits information, visit
https://www.gilead.com/careers/compensation-benefits-and-wellbeing .
Equal Employment Opportunity Statement Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
#J-18808-Ljbffr