Sr Director, Product Quality Lead

Gilead Sciences • Foster City, CA

22h

About The Position

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 Job Functions: Manage a team of PQL professionals. Accountable for end-to-end quality compliance of the assigned product/program, which include but not limited to providing strategic leadership and direction for quality and compliance activities and owns the overall product risk log. Serve as the primary Quality representative in the PDM meeting. Lead Product Quality Teams (PQT) supporting the product/program, and ensure visibility and communication of strategy, key project timelines and CMC milestones. Monitor and review cross-functional process and product data to identify trends to ensure significant quality and compliance risks are identified, mitigated and, if necessary, escalated in a timely manner. Review and approve the strategy for change control(s) impacting the product/program lifecycle. Provide technical oversight of Major and/or Critical Deviations, CAPAs, Biological Product Deviation and Complaints. Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist with regulatory communications as needed (e.g. responses to agency information requests, the Notified Body Option). Provide oversight for changes to drug substance and drug product CMC details. Accountable for PAI/PLI readiness and supports Gilead PAI/PLI inspection preparation efforts and post-PAI/PLI follow up as a Subject Matter Expert with Quality representatives at CXO(s) and Gilead Sites. Support drug substance and drug product technology transfer, and new product launches. Participate in drafting commercial Annual Product Quality Review (APQR) and review/approve Gilead and CMO APQRs for commercial products. Accountable for medical device/ combination product quality compliance: engage/liaise with medical device product engineering, development, and quality teams. Facilitate Analytical Strategy (stability strategy, specifications, Critical Quality Attributes). Perform work that requires independent decision making and the exercise of independent judgment. Serve as the delegate for direct manager, as needed, for meeting and decision making.

Requirements

• 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 andtheories.
• In-depth knowledge in Global requirements/standards for product registration and life-cycle management of product quality.
• Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product.
• Skilled at managing multiple projects and timelines and to facilitate meetings.
• In-depth understanding and execution of Quality Risk Management.
• Ability to track and follow up on actions.
• Excellent in verbal, written and interpersonal communication skills.
• Ability to work in a team-oriented approach to address complex issues in a scientifically sound and compliant way.
• Ability to lead and influence a matrix-based cross-functional team.
• Critical and strategic thinking skills and ability to provide pragmatic, risk-based, and phase appropriate guidance and decision-making even when quality and compliance requirements are not well-defined.
• Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product
• Prior Quality leadership and technical management experience in development and/or commercial programs.
• 15+ 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.
• Demonstrated experience and knowledge in quality assurance in a highly regulated manufacturing environment.
• Direct experience with regulatory health authority submissions (e.g. IND, NDA, BLA, MAA) and/or inspections.
• Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product.

Responsibilities

• Manage a team of PQL professionals.
• Accountable for end-to-end quality compliance of the assigned product/program, which include but not limited to providing strategic leadership and direction for quality and compliance activities and owns the overall product risk log.
• Serve as the primary Quality representative in the PDM meeting.
• Lead Product Quality Teams (PQT) supporting the product/program, and ensure visibility and communication of strategy, key project timelines and CMC milestones.
• Monitor and review cross-functional process and product data to identify trends to ensure significant quality and compliance risks are identified, mitigated and, if necessary, escalated in a timely manner.
• Review and approve the strategy for change control(s) impacting the product/program lifecycle.
• Provide technical oversight of Major and/or Critical Deviations, CAPAs, Biological Product Deviation and Complaints.
• Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist with regulatory communications as needed (e.g. responses to agency information requests, the Notified Body Option).
• Provide oversight for changes to drug substance and drug product CMC details.
• Accountable for PAI/PLI readiness and supports Gilead PAI/PLI inspection preparation efforts and post-PAI/PLI follow up as a Subject Matter Expert with Quality representatives at CXO(s) and Gilead Sites.
• Support drug substance and drug product technology transfer, and new product launches.
• Participate in drafting commercial Annual Product Quality Review (APQR) and review/approve Gilead and CMO APQRs for commercial products.
• Accountable for medical device/ combination product quality compliance: engage/liaise with medical device product engineering, development, and quality teams.
• Facilitate Analytical Strategy (stability strategy, specifications, Critical Quality Attributes).
• Perform work that requires independent decision making and the exercise of independent judgment.
• Serve as the delegate for direct manager, as needed, for meeting and decision making.

Benefits

• 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: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Director