Vice President, Quality
$293,000–$358,000 year
On-site · Watertown, Massachusetts, United States
Job Summary
Vice President of Quality at Remix Therapeutics to architect and lead the quality organization from pre-clinical through potential commercialization. Build the QMS to meet FDA/EMA/ICH standards, lead GxP compliance, and oversee GCP/GMP for clinical programs, vendor qualification, and regulatory submissions. Lead inspections, partner with safety/Pharmacovigilance, oversee CMOs and CROs, and establish a data-driven quality culture. Requires a Masters or higher, 15+ years in pharma/biotech with 10+ years in quality leadership, strong regulatory and inspections experience, oncology familiarity, and ability to operate in a fast-paced, hybrid/virtual environment.
Required Qualifications
- Masters degree or higher in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline
- 15+ years of progressive pharmaceutical/biotech industry experience, with 10+ years in quality management and leadership roles of increasing scope
- Proven track record building, leading, and scaling quality organizations at clinical-stage and/or commercial-stage companies
- Deep expertise in GCP and GMP compliance
- Demonstrated success leading or hosting FDA and/or EMA GxP inspections; direct experience managing inspection responses and regulatory action items
- Expert knowledge of FDA, EMA, and ICH guidelines and regulations applicable across the drug development lifecycle
- Experience providing quality oversight of small molecule CMOs and clinical CROs in a virtual or hybrid operating model
- Exceptional leadership presence, integrity, and judgment; thrives in a dynamic, fast-paced environment where agility and accountability coexist
- Familiarity with oncology drug development and oncology-specific clinical quality considerations
- Working knowledge of EU GMP requirements and experience with dual US/EU regulatory programs
Desired Qualifications
- Masters degree or higher in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline
- 15+ years of progressive pharmaceutical/biotech industry experience, with 10+ years in quality management and leadership roles of increasing scope
- Proven track record building, leading, and scaling quality organizations at clinical-stage and/or commercial-stage companies
- Deep expertise in GCP and GMP compliance
- Demonstrated success leading or hosting FDA and/or EMA GxP inspections; direct experience managing inspection responses and regulatory action items
- Expert knowledge of FDA, EMA, and ICH guidelines and regulations applicable across the drug development lifecycle
- Experience providing quality oversight of small molecule CMOs and clinical CROs in a virtual or hybrid operating model
- Exceptional leadership presence, integrity, and judgment; thrives in a dynamic, fast-paced environment where agility and accountability coexist
- Familiarity with oncology drug development and oncology-specific clinical quality considerations
- Working knowledge of EU GMP requirements and experience with dual US/EU regulatory programs
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