Gilead Sciences, Inc.
Senior Director, Global Supplier Quality
Gilead Sciences, Inc., Foster City, California, United States, 94420
Job Description
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 our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life‑changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Senior Director, Global Supplier Quality Gilead Sciences, Inc. is a research‑based biopharmaceutical company founded in 1987. Together we deliver life‑saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
Working in PDM Global Quality at Gilead Pharmaceutical Development & Manufacturing (PDM) Global Quality delivers on Gilead’s commitment to bring life‑changing therapies to patients through robust Quality processes and systems. Our approach is agile, innovative and collaborative and our teams are committed to the successful delivery of safe life‑changing therapies.
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.
Work collaboratively with internal and external networks to continually improve Gilead’s Global Supplier Quality program, including selection, onboarding, qualification and routine quality and performance oversight of global and local GMP material and commodity suppliers.
Demonstrate leadership skills, extensive working knowledge of managing GMP material and commodity suppliers’ performance and relationships, and exceptional skills in managing a matrix organization.
Understand different material categories supporting GMP manufacturing of different Gilead product modalities.
Influence Gilead’s external network on selection of GMP material and commodity suppliers in alignment with Gilead’s standards.
Be extremely familiar with applicable regulations and requirements in GMP material and commodity supplier management, and clarify the role and responsibilities between marketing authorization holder and contract manufacturing organizations.
Possess strong communication, influencing and negotiation skills; evaluate options and trade‑offs and utilize available resources to achieve the most positive impact to the business; partner with leaders in different PDM functions including Technical Development, Packaging Development and Engineering, Global Manufacturing, Procurement, Regulatory CMC, and the Gilead Site Quality.
Have proven track record in leading Global Supplier Quality program 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, based on the value proposition for Gilead (Integrity, Inclusion, Teamwork, Accountability, Excellence) and available SMEs.
Develop processes to communicate learnings and drive related Supplier Quality improvement initiatives.
Develop a process for exchange of lessons learned across multiple company representatives and identify opportunities for 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 Global Supplier Quality program and ensure maximum productivity and world‑class systems, meeting the needs of all internal and external constituencies with emphasis on process, quality, productivity, budget control, and profitability.
Develop, implement, and monitor Global Supplier Quality program, policies, and procedures to ensure compliance with GxP standards, corporate policies, FDA, EMA, and other regulatory body regulations and guidelines.
Set and drive compliance with department, site and global KPIs.
Evaluate current Global Supplier Quality systems and processes and recommend and implement appropriate enhancements and training to achieve Gilead’s long‑term objectives.
Engage in professional organization representation and benchmarking in industry networks.
Provide guidance to business teams on technical regulatory requirements and lead/assist where needed.
Participate in internal business and technical forums as Quality’s voice for GMP material and commodity suppliers’ oversight.
Conduct regular review and assessment of regulatory intelligence and communicate concerns, trends, gaps, alerts to Quality management timely.
Anticipate potential problems and risks related to regulatory compliance expectations globally.
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, 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 and theories.
In‑depth knowledge of Global requirements/standards for GMP material and commodity suppliers’ life‑cycle management.
Demonstrated ability to develop solutions to complex problems requiring ingenuity, creativity and innovativeness, where precedent may not exist.
Excellent verbal, written, and interpersonal communication skills.
Ability to interact with regulatory agencies and represent Gilead in public forums.
Demonstrated experience and ability to manage a team of highly technical staff.
Expert 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 such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
Prior leadership experience in a complex organization – a must.
Expert knowledge in technical and regulatory requirements pertaining to GMP material and commodity supplier management – a must.
Biopharmaceutical or Pharmaceutical experience – a must.
Prior experience leading Global or Local Supplier Quality organization in a global biotech or pharmaceutical company – a must.
Experience with GMP material and commodity category management covering the different Gilead product modalities – 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 based on role), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans*.
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Equal Employment Opportunity 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 Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnishing information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
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
Every member of Gilead’s team plays a critical role in the discovery and development of life‑changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Senior Director, Global Supplier Quality Gilead Sciences, Inc. is a research‑based biopharmaceutical company founded in 1987. Together we deliver life‑saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
Working in PDM Global Quality at Gilead Pharmaceutical Development & Manufacturing (PDM) Global Quality delivers on Gilead’s commitment to bring life‑changing therapies to patients through robust Quality processes and systems. Our approach is agile, innovative and collaborative and our teams are committed to the successful delivery of safe life‑changing therapies.
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.
Work collaboratively with internal and external networks to continually improve Gilead’s Global Supplier Quality program, including selection, onboarding, qualification and routine quality and performance oversight of global and local GMP material and commodity suppliers.
Demonstrate leadership skills, extensive working knowledge of managing GMP material and commodity suppliers’ performance and relationships, and exceptional skills in managing a matrix organization.
Understand different material categories supporting GMP manufacturing of different Gilead product modalities.
Influence Gilead’s external network on selection of GMP material and commodity suppliers in alignment with Gilead’s standards.
Be extremely familiar with applicable regulations and requirements in GMP material and commodity supplier management, and clarify the role and responsibilities between marketing authorization holder and contract manufacturing organizations.
Possess strong communication, influencing and negotiation skills; evaluate options and trade‑offs and utilize available resources to achieve the most positive impact to the business; partner with leaders in different PDM functions including Technical Development, Packaging Development and Engineering, Global Manufacturing, Procurement, Regulatory CMC, and the Gilead Site Quality.
Have proven track record in leading Global Supplier Quality program 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, based on the value proposition for Gilead (Integrity, Inclusion, Teamwork, Accountability, Excellence) and available SMEs.
Develop processes to communicate learnings and drive related Supplier Quality improvement initiatives.
Develop a process for exchange of lessons learned across multiple company representatives and identify opportunities for 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 Global Supplier Quality program and ensure maximum productivity and world‑class systems, meeting the needs of all internal and external constituencies with emphasis on process, quality, productivity, budget control, and profitability.
Develop, implement, and monitor Global Supplier Quality program, policies, and procedures to ensure compliance with GxP standards, corporate policies, FDA, EMA, and other regulatory body regulations and guidelines.
Set and drive compliance with department, site and global KPIs.
Evaluate current Global Supplier Quality systems and processes and recommend and implement appropriate enhancements and training to achieve Gilead’s long‑term objectives.
Engage in professional organization representation and benchmarking in industry networks.
Provide guidance to business teams on technical regulatory requirements and lead/assist where needed.
Participate in internal business and technical forums as Quality’s voice for GMP material and commodity suppliers’ oversight.
Conduct regular review and assessment of regulatory intelligence and communicate concerns, trends, gaps, alerts to Quality management timely.
Anticipate potential problems and risks related to regulatory compliance expectations globally.
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, 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 and theories.
In‑depth knowledge of Global requirements/standards for GMP material and commodity suppliers’ life‑cycle management.
Demonstrated ability to develop solutions to complex problems requiring ingenuity, creativity and innovativeness, where precedent may not exist.
Excellent verbal, written, and interpersonal communication skills.
Ability to interact with regulatory agencies and represent Gilead in public forums.
Demonstrated experience and ability to manage a team of highly technical staff.
Expert 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 such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
Prior leadership experience in a complex organization – a must.
Expert knowledge in technical and regulatory requirements pertaining to GMP material and commodity supplier management – a must.
Biopharmaceutical or Pharmaceutical experience – a must.
Prior experience leading Global or Local Supplier Quality organization in a global biotech or pharmaceutical company – a must.
Experience with GMP material and commodity category management covering the different Gilead product modalities – 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 based on role), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans*.
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Equal Employment Opportunity 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 Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnishing information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
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