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Executive Director, GMP Quality Assurance

1 month, 1 week ago
United States
Full-time
Executive
Manual QA Tester
Quality Assurance and Testing
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 22

Description

  • Lead the global GMP QA strategy in support of the clinical-to-commercial transition.
  • Build, lead, and scale a high-performing GMP QA team.
  • Develop and execute the GMP QA functional strategy aligned with company objectives and changing business needs.
  • Establish and maintain GMP QA systems for deviations, investigations, CAPAs, change control, complaints, and product disposition.
  • Ensure compliance with global GMP regulations and standards, including FDA, EMA, and ICH requirements.
  • Lead internal audit and regulatory inspection readiness across GMP operations.
  • Oversee GMP QA activities with CMOs, CDMOs, and external testing partners.
  • Manage quality agreements, oversight models, escalation pathways, and performance metrics with external partners.
  • Provide risk-based recommendations and guidance to senior leadership and cross-functional teams.
  • Lead Quality Management Review meetings to drive compliance, continuous improvement, and scalable operations.

Requirements

  • 15+ years of progressive GMP QA experience in pharmaceutical, biotechnology, and/or medical device environments.
  • Deep understanding of global GMP regulations across clinical and commercial operations.
  • Proven experience leading GMP QA organizations through the transition from clinical development to commercial manufacturing, including launch readiness and post-approval operations.
  • Experience building and scaling GMP Quality Systems to support commercial supply.
  • Functional leadership experience with the Veeva Quality Suite (QMS), including system strategy, governance, and compliance.
  • Extensive experience overseeing external manufacturing and testing partners.
  • Direct experience leading regulatory inspections and interactions with global health authorities.
  • Experience managing managers and senior-level professionals.
  • Strong leadership ability to coach and develop teams through change and uncertainty.
  • Strong written and verbal communication skills.
  • Ability to operate effectively in a fast-paced environment with incomplete information.
  • Up to 25% travel is required, including in-person All Hands meetings and travel related to GMP manufacturing.
  • Demonstrated commitment to Apogee’s C.O.R.E. values and ethical decision-making.

Benefits

  • Base salary range of $275,000-$305,000.
  • Performance bonus opportunity.
  • Equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO.
  • Two one-week company-wide shutdowns each year.
  • Dedicated paid sick leave.
  • Access to professional development resources and growth opportunities.

Interested in this position?

Apply directly on the company website

Apply Now

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