Supports and oversees the proactive and risk-based Quality Strategy implementation in the clinical development activities
Ensures that a proactive, risk-based Quality Strategy is established and implemented for trials assigned
Collaborates with key internal stakeholders to ensure that clinical trial risks are detected and remediated
Is an active member of the Clinical Trial Teams, participating in meetings and providing guidance
Maintains a state of inspection readiness and quality dashboard outlining key quality aspects
Interacts with external partners to ensure adequate quality oversight of clinical activities
Participates in the setup and management of strategic and pro-active risk based quality oversight
Supports GCP Health Authorities inspections preparation / facilitation / follow-up activities
Oversees ongoing inspection readiness activities and develops inspection narratives
Collaborates on the creation and implementation of Quality Agreements with CROs and clinical vendors
Contributes to a culture of quality in BioNTech Global Development Organization

University degree in life sciences
Minimum of 5-8 (five to eight) years of experience in a Good Clinical Practice (GCP)-regulated environment
Minimum of 3-5 (three to five) years in a Quality Assurance (QA) position
Inspection management experience preferred

Medical, Dental and Vision Insurance
Life, AD&D, Critical Illness Insurance
Pre-tax HSA & FSA, DCRA Spending Accounts
Employee Assistance & Concierge Program (EAP) available 24/7
Parental and Childbirth Leave & Family Planning Assistance
Sitterstream: Virtual Tutoring & Childcare Membership
Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
401(K) Plan with Company Match
Tuition Reimbursement & Student Loan Assistance Programs
Wellbeing Incentive Platforms & Incentives
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance

Associate Director, Clinical Quality Assurance

Key skills