Citytherapeutics
VP, Quality Assurance
Cambridge, MA. Posted 26 days ago
The role
The VP of Quality Assurance will lead the quality assurance strategy and systems. This person will design, implement, and improve the Quality Management System and ensure compliance with cGXP regulations.
What you will do
- Define and lead the enterprise-wide Quality Assurance strategy
- Lead quality risk management activities
- Build, develop, and retain a high-performing QA team
- Establish and monitor quality KPIs, metrics, and dashboards
- Provide executive oversight of all cGXP activities
- Own and continuously improve the Quality Management System
- Drive and maintain a state of continuous inspection readiness
- Collaborate with Regulatory Affairs on regulatory submissions
- Serve as the primary QA lead during regulatory agency inspections and audits
- Establish and maintain a vendor qualification and audit program
Required qualifications
- Bachelor's degree in life sciences, pharmacy, chemistry, or a related field
- 15+ years of progressive Quality Assurance experience in the biopharmaceutical or pharmaceutical industry
- Minimum of 5 years in a senior or executive leadership role
- Demonstrated experience building and scaling QA functions in a clinical-stage or growth-phase biopharmaceutical company
- Working knowledge of international regulatory frameworks including EMA, ICH, and PMDA requirements
- Proven track record leading successful regulatory inspections (FDA, EMA, or equivalent)
- Extensive experience managing CMO, CDMO, and CRO quality relationships
- Comprehensive, hands-on expertise in GMP and GCP regulations
Nice to have
- Advanced degree (MS, PhD, PharmD)
- Experience across multiple modalities including biologics, and/or cell and gene therapies
- Prior experience supporting a product through BLA/NDA approval and commercial launch
Benefits
- Annual bonus
- Equity compensation
- Competitive benefits package
Before you apply
- City Therapeutics is accepting resumes/CVs from direct applicants only
- Recruitment Agency submissions will not be accepted at this time
About the company
City Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing transformative therapies for patients with serious unmet medical needs.