Associate Director, Quality Control

Gilead Sciences • Foster City, CA

1d • Onsite

About The Position

The Associate Director, Quality Control - Biologics QC Lead provides strategic Quality Control leadership for assigned biologics programs across the product lifecycle. The role is the primary QC representative for those programs and partners with internal and external stakeholders, including Analytical Development, Quality Assurance, and Regulatory Affairs. The Associate Director establishes phase-appropriate QC and analytical strategies that support clinical development, technology transfer, process validation, regulatory submission, commercialization, and lifecycle management while ensuring control strategies are scientifically sound, compliant, and executable.

This position is based in Foster City, California. It requires the ability to travel domestically and internationally as needed to support internal sites, external partners, program activities, and regulatory or inspection-readiness needs. The successful candidate works effectively across global teams and time zones and manages multiple programs, priorities, and critical milestones.

Requirements

• Ph.D. with 2+ years of experience, M.S. with 8+ years of experience, or B.S. with 10+ years of industrial experience.
• 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 activities.
• 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.
• 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, including distinguishing regulatory or GMP requirements from internal practices and developing pragmatic, scientifically justified solutions.
• Strategic thinking, sound independent judgment, and ability to connect analytical issues to broader product, filing, supply, and lifecycle risks.
• Effective executive and technical communication skills, including presenting complex issues, options, risks, and recommendations to senior leadership and cross-functional governance teams.
• Strong collaboration, negotiation, and influencing skills, including leading without direct authority and establishing effective relationships with internal functions and external partners.
• Commitment to people development, inclusion, accountability, operational excellence, continuous improvement, and a strong quality culture.
• Ability to travel domestically and internationally as needed, work effectively across global teams and time zones, and manage multiple programs, priorities, and critical milestones.

Nice To Haves

• An advanced science degree such as an MS, MD, PharmD, or PhD.

Responsibilities

• Serve as 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.
• 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.
• Oversee testing 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 involving analytical methods, specifications, validation, stability, and QC operations.
• Lead cross-program initiatives to 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, and budget management.
• Select and oversee external laboratories, consultants, and technical service providers.

Benefits

• May be eligible for a discretionary annual bonus.
• May be eligible for discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.

What This Job Offers

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