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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 Requirements
- 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 activities.Pre
- 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: $182,070.00 - $235,620.00. 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*.
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.
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