Quality Site Lead (Sr. Manager) - Foster City

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.

Job Description

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North, South and Central America, Europe, Africa, Asia and Australia. Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic status.

Gilead Sciences is currently seeking a Quality Site Lead (QSL) to provide quality oversight of GMP activities at assigned Gilead CXOs, supporting the manufacture of Biologics intermediates, drug substances and drug products for clinical and commercial distribution. This role is needed to ensure Gilead’s CXOs are proactively managed from a quality and compliance perspective.

Job Functions:

• Primary Pharmaceutical Development and Manufacturing ( PDM ) Quality contact a ccountable for proactive quality oversight for assigned Gilead CXO partners /sites .

• Assure CXOs meet Gilead’s quality, regulatory and compliance standards, to ensure a sustainable delivery of quality product s to patients .

• Key representative on Product Quality Teams for assigned CXO.

• Ensure contract manufacturers are compliant and ready for regulatory inspections and monitor progress during inspection . Support onsite inspections to ensure compliance and readiness, as needed.

• Facilitates quality events for CXOs.

• Partner with internal stakeholders such as Global External Manufacturing, Global Supply Chain, Pharmaceutical Development, and Reg ulatory Chemistry, Manufacturing and Controls (RA CMC ) , to identify solutions and processes and align with key partners on implementation of new requirements ; proactively address.

• Lead escalations for critical quality issues .

• Evaluate current q uality systems and processes and recommend and implement appropriate enhancements and trainings to ensure the achievement of Gilead long-term objectives .

• Monitor CXO site trends, holding CXO accountable to established performance criteria and QAG requirements .

• Ensure GMP documentation is accurate and compliant with internal and external standards and requirements.

• Provide guidance to the business teams on regulatory requirements and assist where needed.

• Participate on C X O Business Review Meetings (BRMs) as Quality’s voice for the contract organizations’ oversight.

• Establish and f oster meaningful Quality to Quality relationships between Gilead and C X Os.

• Conduct regular review and assessment of regulatory i ntelligence and communicate any concerns, trends, gaps, alerts to Quality management in a timely fashion .

• Partner with Manufacturing, Development, Global Supply Chain, Global QC and Outsourcing to deliver on the production plan.

• T hink and act globally to anticipate potential problems and risks related to regulatory compliance expectations .

• Champion Qual i t y Ri s k M a n age m e n t , i d e n t i f y i n g k ey ris k s im p ac t i n g CXO performance.

• Accountable for PAI/PLI readiness for assigned CXO sites.

• Travel to CXO site(s) to provide Quality oversight of critical manufacturing activities, as required .

• Up to 20% travel based on strategic plan .

• May manage a team of Quality Professionals.

Knowledge, Experience and Skills:

• Knowledgeable in quality requirements pertaining to manufacturing , testing, packaging, labeling, facility, utility , equipment and process validation, cleanroom classification and qualification , new product introduction, multi-product facility control, contamination control strategy, technology transfer, contract operati on s , product release, disposition , and distribution.

• I n-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.

• Knowledgeable in Global requirement/standards for product registration and life cycle management of product quality.

• Demonstrated ability to develop solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness, and where precedent may not exist.

• E xcellent verbal, written, and interpersonal communication skills.

• Experienced in prioritizing workload to address competing projects and timelines .

Basic Qualifications:

• 8+ years of relevant experience and a bachelor’s degree in science or related fields ; or 6+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.

• Knowledge in technical and regulatory requirements pertaining to manufacturing , product lifecycle management , and outsourced operations a must .

• Biopharmaceutical or Pharmaceutical experience a must .

• Prior experience leading contract manufacturing /testing operations or overseeing contract manufacturing operations a must .

• Experience with different pharmaceutical modalities, e.g., active pharmaceutical ingredients, parenteral, biologics, and medical device preferred.

The salary range for this position is: $157,590.00 - $203,940.00. 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*.

For additional benefits information, visit:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

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 [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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 a 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 furnish 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.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.