Director, Clinical Quality Assurance
BioNTech•Cambridge, MA
•$168,100 - $268,700•Hybrid
About The Position
As Director, Clinical Quality Assurance Compliance you will lead quality assurance activities across clinical development programs in global teams. This role focuses on implementing a proactive, risk-based quality strategy, ensuring GCP compliance, fostering a culture of quality within the Global Development Organization whilst supporting delivery of our clinical trial portfolio.
Requirements
- University degree in life sciences; advanced degree preferred
- Profound professional experience (beyond 10 years) in a GCP-regulated environment
- Strong GCP expertise gained in a senior Quality Management and / or Clinical Operations role.
- Strategic and Risk-based mindset with experience developing quality strategies at program level
- Solid understanding of global clinical regulations and guidelines (ICH, FDA, EMA, MHRA)
- Experience in team leadership and development (in the GCP environment preferred)
- Experience in managing, hosting or supporting regulatory authority inspections (EMA/FDA/MHRA)
- Proficiency in MS Office and electronic quality management systems
Responsibilities
- Develop and implement a proactive, risk-based Clinical Quality Strategy for assigned high-priority trials or programs, ensuring inspection readiness and GCP compliance
- Collaborate with internal teams, collaboration partners as well as external vendors (e.g. CROs) to identify, investigate, and remediate clinical trial risks and quality issues, including CAPAs and effectiveness checks
- Actively contribute to Clinical Trial teams by providing quality guidance and reviewing key study documentation
- Enable continuous inspection readiness and compliance with GCP, regulatory requirements, and internal standards
- Lead or support inspection preparation, facilitation, and follow-up activities
- Review and manage Quality Agreements with CROs and other vendors, ensuring compliance with agreed standards
- Lead and develop a team, fostering transparency and proactive communication
- Drive a culture of quality and continuous improvement across the Global Development Organization, including authoring and reviewing clinical quality procedures.
- Acting as an ambassador for quality: ensuring that quality is an enabler of delivery.
Benefits
- competitive remuneration packages
- annual bonus & equity (bonus and equity is variable and dependent on company and individual performance)
- benefits
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What This Job Offers
Job Type
Full-time
Career Level
Director
