Director, Quality Assurance *PC 586
$212,237–$249,690 year
On-siteSan Jose, California, United States
Job Summary
Director, Quality Assurance at Miltenyi Biotec is responsible for strategic and operational QA leadership across Quality Operations and Quality Systems with oversight of CMC Quality and site-wide compliance at the Miltenyi San José CDMO site, covering GMP manufacturing from starting materials to patient-ready products. The role includes QA leadership on supplier quality, health authority inspections and client audits, technical transfers, and support of client commercialization programs; building and developing a high-performing QA team; and guiding regulatory strategy and compliance programs. Responsibilities include ensuring inspection readiness, aligning resources to project and operational timelines, maintaining QMS, overseeing batch release decisions for GMP starting materials, intermediates, and drug products, and acting as QA representative during audits and regulatory interactions. The ideal candidate possesses extensive experience with BLA/IND submissions, regulatory inquiries, GMP/GDP compliant QMS, and leadership in a pharmaceutical/biotech/ATMP environment, with strong cross-functional collaboration and a proven ability to translate strategy into actionable plans while maintaining regulatory confidence and quality performance.
Required Qualifications
- BS/Engineering, additional qualification in Quality Management, Regulatory Affairs or related discipline is a plus; PhD or Masters of Science/Engineering; Approx. 15 years applicable experience in Technical Operations (preferably manufacturing, QA and/or QC rel. to ATMPs) in the Pharmaceutical, Med…
- Experience authoring/approving/reviewing BLA/IND submissions and subsequent responses to questions from regulatory bodies (e.g. FDA).
- Experience with maintaining a Quality Management System acc. to current GMPs/GDPs and supported by electronic workflows, leading health authority inspections and internal/external/customer audits.
- Experience with general chemistry and/or microbiology methods and laboratory operations.
- Experience with manufacturing processes, technical transfers and analytical (chemistry/microbiology) methods and laboratory operations.
- In depth knowledge of international GxP requirements and pharmacopeia (especially 21 CFR210/211/610/820, EU GMP, ATMPs, ICH, ISO, USP, Ph EU, JP).
- Proven leadership skills.
- Effective verbal and/or written communicate at all levels of organization.
- Demonstrated problem solving.
- Able to translate strategy to action, work effectively in ambiguous situations.
- Proven track record of increasing customer base service satisfaction.
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