Director, Quality Control

Role Overview

• Develop and execute the enterprise QC strategy to support clinical product testing, Phase 3 clinical trials, PPQ, BLA submission, and commercial launch.
• Build scalable QC systems, processes, governance, and organizational capabilities aligned with commercial-stage operations.
• Establish and maintain analytical control strategies for drug substance (DS), drug product (DP), and combination products.
• Ensure inspection readiness across QC operations, documentation, data integrity, and external partner networks.
• Serve as a strategic advisor to Quality and CMC on analytical and QC-related risks, compliance considerations, and commercialization readiness.
• Lead and provide oversight of analytical method qualification, validation, transfer, verification, and lifecycle management in alignment with ICH, FDA, EMA, and global regulatory expectations.
• Ensure all release, characterization, and stability-indicating methods are validated and commercially sustainable prior to BLA submission.
• Oversee analytical comparability strategies, method bridging activities, and technology transfers across CMOs and contract laboratories.
• Drive continuous improvement of analytical control strategies and testing programs through data trending and lifecycle management principles.
• Ensure effective governance of reference standards, critical reagents, and assay performance monitoring programs.
• Partner cross-functionally with Manufacturing, MSAT, and CMC teams to ensure QC readiness for PPQ execution and commercial manufacturing.
• Provide QC oversight for in-process, release, and stability testing supporting validation campaigns and commercial supply.
• Support continued process verification (CPV) programs through statistical trending, data analysis, and ongoing monitoring of product quality attributes.
• Ensure timely and compliant batch disposition support through robust data review and issue escalation processes.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related scientific discipline; advanced degree preferred.
• 10+ years of progressive Quality Control and analytical experience within GMP biopharmaceutical environments, including late-stage clinical and commercial readiness activities.
• Experience overseeing GMP analytical testing for clinical-stage biologic DS and DP, including release, stability, in-process, and/or comparability testing performed by CMOs or contract testing laboratories.
• Demonstrated experience supporting BLA and/or MAA submissions, regulatory inspections, and commercial launch preparation.
• Deep expertise in biologics analytical methods, including chromatographic, electrophoretic, cell-based, compendial, and microbiological techniques.
• Extensive experience with analytical method validation, lifecycle management, comparability, and technology transfer.
• Strong knowledge of cGMP regulations and global regulatory expectations, including 21 CFR Parts 210, 211, and 4.
• Hands-on experience supporting combination products such as pre-filled syringes, autoinjectors, or related delivery systems.
• Proven success leading QC support for PPQ campaigns, validation activities, and commercial manufacturing readiness.
• Demonstrated experience managing CMOs, contract laboratories, and global external testing networks.
• Strong understanding of data integrity principles, electronic systems, and QC compliance requirements.
• Proven ability to build and scale Quality organizations in a fast-paced biotech environment.
• Excellent leadership, communication, and cross-functional collaboration skills with the ability to influence at all organizational levels.

Benefits

• Competitive salary and benefits package.
• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.