Director, Quality Site LeadGilead Sciences, Inc. • Foster City, CA, United States
Director, Quality Site Lead
Gilead Sciences, Inc. • Foster City, CA, United States
3 days ago
Job type
- Full-time
Job descriptionPrimary Pharmaceutical Development and Manufacturing (PDM) Quality contact accountable for proactive quality oversight for assigned Strategic 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 member of Business Review Meetings with CXO as Quality’s voice for the contract organizations’ oversight. Maybe member or backup member of Joint Steering Committee. 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. Accountable for multiple external QA functions, including quality events, validation, and release / disposition. Partner with internal stakeholders such as Global External Manufacturing, Global Supply Chain, Pharmaceutical Development, and Reg 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. Travel to CXO site(s) to provide Quality oversight of critical manufacturing activities, as required. 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. 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. May back up Pillar Lead, as needed. Champion Quality Risk Management, identifying key risks impacting CXO performance. Ensure PAI / PLI Readiness for assigned CXO sites. Up to 20% travel based on strategic plan. Manages a team of Quality Professionals. 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. Expert in prioritizing workload to address competing projects and timelines. 12+ years of relevant experience and a bachelor’s degree in science or related fields; or 10+ 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 experience leading, developing and managing people. Knowledge in technical and regulatory requirements pertaining to manufacturing, testing,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. Significant experience with different pharmaceutical modalities, e.g., active pharmaceutical ingredients, parenteral, biologics, and medical device preferred. Prior people management experience required. Broad experience across several areas like CMO QA, Validation, Drug development experience, packaging / labeling and understanding of Parenteral, OSD, and Biologics.
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Site Director • Foster City, CA, United States
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