Quality Site Lead (Sr. Manager) - Foster City

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 accountable 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 products 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 Regulatory 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 quality 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 CXO Business Review Meetings (BRMs) as Quality’s voice for the contract organizations’ oversight.

• Establish and foster meaningful Quality to Quality relationships between Gilead and CXOs.

• Conduct regular review and assessment of regulatory intelligence 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.

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

• Champion Quality Risk Management, identifying key risks impacting 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 operations, product release, disposition, and distribution.

• 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.

• 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.

• Excellent 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.