Executive Director, GMP Quality Assurance

Responsibilities

• Head of GMP QA and member of the QA Leadership Team
• Build, lead, and scale a high‑performing GMP QA team
• Develop and execute the GMP QA functional strategy, ensuring alignment with company objectives and evolving clinical‑to‑commercial needs
• Establish a clear GMP QA vision that enables inspection readiness, scalability, and sustainable operations
• Provide oversight of GMP QA systems, including deviations, investigations, CAPAs, change control, complaints, and product disposition
• Ensure compliance with applicable global GMP regulations and standards (e.g., FDA, EMA, ICH)
• Lead organizational readiness for GMP internal audits and regulatory inspections
• Provide strategic oversight of GMP QA across CMOs, CDMOs, and external testing partners
• Ensure effective quality agreements, oversight models, escalation pathways, and performance metrics are in place and actively managed
• Exercise sound judgment in resolving quality issues with external partners in a timely and compliant manner
• Engage effectively with leadership and key cross‑functional partners, bringing forward clear recommendations and risk‑based perspectives
• Lead the development and presentation of Quality Management Review meetings for GMP QA to highlight compliance needs and to foster continuous improvement initiatives to support speed, clarity, and scalability
• Ideal Candidate
• 15+ years of progressive GMP QA experience within pharmaceutical, biotechnology, and/or medical device environments, with deep understanding of global GMP regulations across clinical and commercial operations
• Proven track record leading GMP QA organizations through the transition from clinical development to commercial manufacturing, including launch readiness and post approval operations
• Demonstrated success building, scaling, and sustaining GMP Quality Systems to support commercial supply, including serving as functional lead for the Veeva Quality Suite (QMS) with accountability for system strategy, governance, and compliance across internal teams and external partners
• Extensive experience overseeing external manufacturing and testing partners, and directly leading regulatory inspections and interactions with global health authorities
• Significant leadership experience, including managing managers and senior level professionals; effective at coaching and developing leaders through change and uncertainty
• Ability to create and clearly articulate a GMP QA vision aligned with company strateg

Benefits

Additional Information

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company's most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today's standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: C aring, O riginal, R esilient and E goless and a commitment to refusing to stop at "good enough". If this sounds like you, keep reading! Role Summary We are seeking an Executive Director of GMP Quality Assurance (QA) to serve as a senior quality leader responsible for developing, leading, and executing the global GMP QA strategy in support of a transition from clinical development to commercial readiness. This role verifies compliance with cGMP regulations, company policies and procedures, and industry standards, while deliberately designing quality systems that enable speed, clarity, and confident decision-making as the company scales. The Executive Director partners closely with cross-functional teams and external manufacturing and testing partners ensuring high standards of product quality and data integrity across GMP operations. They build and lead a high‑performing GMP QA team, provide strategic oversight of audits and inspections, and serve as a trusted advisor to senior leadership on GMP QA risk management. This position reports to the Head of QA.

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