Associate Director, Quality Control

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.
• 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.