14 часов назад
Vice President, Quality Assurance (Oncology)
315 000 - 340 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Vice President, Quality Assurance (Oncology): Defining and driving global quality strategy, systems, and governance across clinical development, manufacturing, pharmacovigilance, and commercial readiness with an accent on GCP, GMP, GPV, inspection readiness, and patient safety. Focus on leading senior Quality teams, overseeing CRO/CMO/CDMO and PV vendor networks, and managing risk-based quality systems through late-stage development and commercialization.
Location: Based out of the San Francisco, California or Boston, Massachusetts office; some travel required.
Salary: $315,000–$340,000 annual base pay, plus equity, bonus, and benefits.
Company
is a clinical-stage biopharmaceutical company developing oncology therapies for metastatic breast cancer, including palazestrant and OP-3136.
What you will do
- Define and drive a unified, phase-appropriate global Quality strategy across the full product lifecycle.
- Lead Quality functions across GCP, GMP, and GPV, establishing governance, accountability, metrics, and escalation pathways.
- Oversee clinical quality, CRO management, patient safety, data integrity, and inspection-ready clinical programs.
- Guide GMP Quality, manufacturing scale-up, CMO/CDMO oversight, CMC, validation, supply chain readiness, and commercialization preparation.
- Oversee pharmacovigilance quality systems, vendors, compliance, safety surveillance, and benefit-risk evaluation.
- Lead regulatory inspection preparation and execution, risk-based audits, and proactive quality and compliance risk mitigation.
Requirements
- Advanced degree in Life Sciences or a related discipline, such as a PhD, PharmD, or MS.
- Deep knowledge of FDA, EMA, ICH, global GxP, and pharmacovigilance requirements.
- Expertise across GCP, GMP, and GPV Quality domains, including Quality systems, governance, and inspection readiness.
- 15+ years of Quality experience in biotech or pharma with increasing scope and responsibility.
- Significant experience leading senior teams, global vendor networks, regulatory inspections, and interactions with health authorities.
- Experience supporting programs from clinical development through late-stage development or commercial readiness, preferably in oncology.
Culture & Benefits
- Mission-driven work focused on improving outcomes for patients with breast cancer and other cancers.
- Culture emphasizing quality, integrity, patient focus, adaptability, learning, and continuous improvement.
- Competitive compensation and benefits package, including equity and bonus opportunities.
- Open, flexible, and collaborative work environment supporting long-term professional development.
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