Executive Director – GMP Quality Assurance

Apogee Therapeutics

Senior quality leader at Apogee Therapeutics guiding GMP QA strategy for clinical to commercial operations. Overseeing compliance, quality systems, and leading high-performing QA teams.

Posted 4/20/2026full-timeRemote • 🇺🇸 United StatesLead💰 $275,000 - $305,000 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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 strategy, establish trust and credibility across teams, and set clear direction while adapting leadership style to organizational and individual needs
Sound, unbiased judgment in complex and ambiguous situations; makes pragmatic, well-reasoned decisions, takes full ownership of outcomes, proactively addresses challenges, seeks feedback, and continuously adapts strategies based on evolving risks and business needs
Strong written and verbal communication skills
Ability to operate effectively in a fast-paced, evolving environment with incomplete information
Demonstrated commitment to Apogee’s C.O.R.E. values and ethical decision-making
Position requires up to 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year and travel related to GMP manufacturing

Benefits

Comp & perks

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

GMP QAGMP Quality Systemsregulatory inspectionsdeviationsinvestigationsCAPAschange controlcomplaintsproduct dispositionVeeva Quality Suite

Soft Skills

leadershipcoachingcommunicationstrategic oversightdecision-makingtrust buildingadaptabilityproblem-solvingcollaborationcontinuous improvement