2 дня назад
Vice President Quality Assurance
315 000 - 340 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Vice President Quality Assurance (GCP/GMP/GPV): Defining and driving global quality strategy, systems, and governance across clinical development, manufacturing, pharmacovigilance, and commercial readiness with an accent on patient safety, data integrity, and inspection readiness. Focus on leading senior Quality teams, overseeing CRO/CMO/CDMO and PV vendors, and managing risk-based regulatory inspections across the product lifecycle.
Location: Based out of the Boston, Massachusetts or San Francisco, California office; travel required as needed.
Salary: $315,000–$340,000 annually, plus equity, bonus, and benefits.
Company
is a clinical-stage biopharmaceutical company developing oncology therapies, including palazestrant and OP-3136, for patients with metastatic breast cancer and other solid tumors.
What you will do
- Define and execute a pragmatic, phase-appropriate global Quality strategy across the full product lifecycle.
- Lead Quality governance and senior leadership across GCP, GMP, and GPV.
- Build scalable Quality Management systems, metrics, reporting, and risk-management frameworks.
- Oversee clinical quality, CRO management, manufacturing quality, CMO/CDMO oversight, and pharmacovigilance vendors.
- Prepare the organization for regulatory inspections and support clinical, manufacturing, safety, CMC, validation, and supply-chain readiness.
- Represent Quality in executive decision-making and cross-functional work with Regulatory, Clinical, Manufacturing, and other functions.
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 and inspection readiness.
- 15+ years of Quality experience in biotech or pharma, with increasing scope and responsibility.
- Significant people-management experience, including leadership of senior team members.
- Experience with global CRO, CMO, CDMO, and pharmacovigilance vendor networks, regulatory inspections, health authorities, and programs progressing toward commercialization.
Culture & Benefits
- Work in a fast-paced, evolving clinical-stage biotech environment focused on oncology and patient impact.
- Culture centered on quality, integrity, patient focus, adaptability, and continuous learning.
- Competitive compensation and benefits package, including equity and bonus.
- Open, flexible, and friendly work environment with opportunities for long-term career development.
- Equal-opportunity workplace that values diverse expertise, backgrounds, and experiences.
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