Executive Director – GMP Quality Assurance

🕒 Abril 20

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Apogee Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🧬 Biotecnologia

💊 Farmacêutico

💰 $149.000.000 Series B em 2022-12

Biotechnology • Pharmaceuticals

Apogee Therapeutics é uma empresa de biotecnologia em fase clínica focada no desenvolvimento de novos biológicos para o tratamento de distúrbios inflamatórios e imunológicos. A empresa mira mercados principais em doenças inflamatórias e imunológicas como dermatite atópica, asma, doença pulmonar obstrutiva crônica, esofagite eosinofílica e outras condições relacionadas. A Apogee Therapeutics busca reformular o padrão atual de cuidados ao avançar terapias com anticorpos que visam mecanismos biológicos bem estabelecidos, com potencial para atender questões dermatológicas, respiratórias e gastroenterológicas. A empresa está comprometida em criar um ambiente de trabalho psicologicamente seguro enquanto prioriza opções de tratamento inovadoras para aqueles que vivem com essas condições.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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