Director, GMP Quality Assurance
Director leads GMP QA programs to ensure compliance, audits and ongoing quality improvements for biologics manufacturing.
- Remote • Worldwide
- Full Time
- $210,000 – $235,000/year
- Min. 10 YOE
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Director leads GMP QA programs to ensure compliance, audits and ongoing quality improvements for biologics manufacturing.
Lead end-to-end clinical supply chain for multiple programs, ensuring timely delivery of investigational products globally.
Lead operational standards for global clinical trials, optimize resources, and drive process improvements across programs.
Leads global GMP QA strategy, audits, and risk management to scale from clinical to commercial.
Lead clinical operations planning and program management for dermatology or respiratory programs, building study plans and tracking KPIs.
Lead QC analytical testing, method lifecycle activities, and data review to ensure cGMP compliance across development pipeline.
Senior Manager leads clinical system programs end-to-end, collaborating across Clinical, IT, Quality and vendors to ensure compliant, scalable system implementations and integrations.
Plans, tracks and manages logistics around biomarker sample collection across clinical trials with vendor oversight and data delivery timelines.
Senior commercial strategist guiding 5-year U.S. roadmap and cross-functional go-to-market plans.
Lead analytical development for monoclonal antibodies and biologics, coordinating cross-functional teams to advance early to late phase programs.
Lead statistical design and analysis across clinical studies, coordinating CROs and regulatory interactions.
Lead MSAT activities for late-stage biologics; collaborate with CDMOs to ensure scalable DS production and successful tech transfers.
Medical director to support dermatology/immunology studies including protocol development, medical monitoring, and cross-functional collaboration.
Lead and expand an MSL team in the East region, coaching, territory planning, and cross-functional collaboration to support clinical trials and strategy.
Regulatory affairs lead for submissions to FDA and ex-US agencies, coordinating cross-functional teams and publishing.
Provide technical leadership on PFS process development, oversee GMP drug product manufacturing, and drive tech transfer to CDMOs for late-stage and commercial programs.
Oversee global clinical trial operations, CROs, and data quality to ensure regulatory-ready submissions.
Senior-manager coordination of medical congress and publication activities, including cross-functional planning and compliant execution.
Lead statistical programming activities for clinical trials, manage CROs, develop processes, and mentor programmers.
Lead global regulatory planning and coordination for IND/CTA/BLA/NDA/MAA submissions across regions with PMO-driven Smartsheet execution.
Lead data management activities in clinical trials, coordinating CROs and ensuring regulatory-ready datasets.