Associate Director, Clinical Quality Assurance

Responsibilities

• Implement proactive, risk-based quality strategies for assigned clinical trials to ensure compliance with GCP and regulatory requirements.
• Collaborate with internal stakeholders and external partners (CROs/vendors) to detect, investigate, and remediate clinical trial risks and quality issues.
• Manage Corrective and Preventive Actions (CAPAs) and effectiveness checks to address root causes of deviations.
• Maintain inspection readiness through quality dashboards, development of inspection narratives, and coordination of mock inspections.
• Support Health Authority inspections by preparing sites, ensuring document availability, and providing back-room or remote support.
• Contribute to the organizational culture of quality by mentoring team members and supporting continuous improvement initiatives.
• Author and review procedural documents covering clinical quality aspects.

Requirements

• University degree in life sciences.
• 5-8 years of experience in a Good Clinical Practice (GCP)-regulated environment.
• 3-5 years of experience in a Quality Assurance (QA) position.

Preferred Qualifications

• Proven experience in inspection management.

Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(K) plan with company match.
• Paid Time Off including vacation, sick leave, and a year-end U.S. shutdown.
• Tuition reimbursement and student loan assistance programs.
• Parental and childbirth leave.
• Professional development programs and wellbeing incentives.

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We focus on addressing high medical needs, such as cancer and infectious diseases, through a community of innovators and scientists driven by a passion for advancing medicine and improving global health.