Associate Director, Quality Control

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

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Job Description

The Associate Director Quality Control - Biologics QC Lead provides strategic Quality Control leadership for assigned biologics programs across the product lifecycle. The role serves as the primary QC representative and partners with internal and external stakeholders such as Analytical Development Quality Assurance Regulatory Affairs.

The Associate Director establishes phase-appropriate QC and analytical strategies that enable clinical development technology transfer process validation regulatory submission commercialization and lifecycle management while ensuring scientifically sound compliant and executable control strategies.

Job Responsibilities:

• Serve as the QC Lead and primary Quality Control point of contact for assigned biologics programs; represent QC on product teams and governance forums and provide clear risk-based recommendations to support program decisions.
• Develop and maintain phase-appropriate end-to-end QC strategies for biologic drug substance drug product intermediates and relevant materials integrating specifications analytical methods sampling release stability reference standards and critical reagents.
• Own or provide senior oversight of specifications and analytical methods.
• Provide QC oversight for testing performed at internal laboratories CMOs/CDMOs and contract testing laboratories; establish governance expectations metrics escalation pathways and sustainable testing-network strategies.
• Provide scientific and quality guidance for significant deviations OOS/OOT or atypical results method-performance issues stability trends comparability questions and laboratory investigations.
• Provide QC subject-matter expertise for CMC regulatory content health-authority questions and interactions inspections and readiness activities related to analytical methods specifications validation stability and QC operations.
• Lead cross-program initiatives that strengthen QC governance specification and control-strategy practices analytical lifecycle management procedures templates standard work and appropriate harmonization across modalities.
• Lead coach and develop QC professionals and matrix teams.
• Support departmental strategy portfolio and resource prioritization operating plans budget management and selection and oversight of external laboratories consultants and technical service providers.
• This position is based in Foster City California. Ability to travel domestically and internationally as needed to support internal sites external partners program activities and regulatory or inspection-readiness needs.
• Ability to work effectively across global teams and time zones and to manage multiple programs priorities and critical milestones.

Basic Requiremen ts

• Ph.D. with 2 years experience OR M.S. with 8 years experience OR B.S. with 10 years industrial experience
• An advanced science degree such as MS MD PharmD or PhD is desirable

Preferred Qualifications

• Extensive progressive experience in biopharmaceutical or pharmaceutical Quality Control analytical development manufacturing sciences or a related technical quality function with substantial experience supporting biologics.
• Demonstrated experience developing and implementing analytical control strategies specifications method qualification/validation method transfer stability comparability reference-standard and analytical lifecycle strategies.
• Experience supporting complex early- and late-stage clinical programs including late-stage development process validation/PPQ regulatory submissions launch readiness and product lifecycle management.
• Experience providing technical and quality oversight of CMOs CDMOs CROs and contract testing laboratories including investigation and issue-resolution activities.
• Demonstrated success leading people and matrix teams managing multiple priorities influencing senior stakeholders and driving decisions in a complex cross-functional environment.
• Experience authoring or reviewing CMC regulatory content and supporting health-authority questions inspections or regulatory-readiness
• In-depth working knowledge of current Good Manufacturing Practices pharmaceutical quality systems data integrity principles and applicable global regulatory expectations for clinical and commercial biologics.

Knowledge Skills & Competencies

• Strong scientific knowledge of biologics characterization and testing including physicochemical biochemical biological microbiological and safety-related methods relevant to drug substance and drug product.
• Strong understanding of phase-appropriate analytical development and QC expectations control strategy specifications comparability stability method validation and transfer and analytical lifecycle management.
• Excellent scientific problem-solving and risk-assessment skills with the ability to distinguish regulatory or GMP requirements from internal practices and to develop pragmatic scientifically justified solutions.
• Demonstrated strategic thinking sound independent judgment and the ability to connect individual analytical issues to broader product filing supply and lifecycle risks.
• Effective executive and technical communication skills including the ability to present complex issues options risks and recommendations clearly to senior leadership and cross-functional governance teams.
• Strong collaboration negotiation and influencing skills including the ability to lead without direct authority and establish effective relationships with internal functions and external partners.
• Demonstrated commitment to people development inclusion accountability operational excellence continuous improvement and a strong quality culture.

The salary range for this position is: $182070.00 - $235620.00. 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*.

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Please apply via the Internal Career Opportunities portal in Workday.

Required Experience:

Director