Quality Assurance Specialist ensuring compliance in pharmaceutical materials and processes. Oversight on new product introductions and quality assurance in a hybrid environment.
About the role
- Associate Director Clinical QA Compliance ensuring quality and integrity of clinical development activities at BioNTech. Leading the proactive, risk-based Quality Strategy implementation across clinical trials.
Responsibilities
- 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
- Maintains a state of inspection readiness/quality dashboard that outlines key quality aspects
- Supports the GDO functions as well as other QA groups, as necessary, for GCP Health Authorities inspections preparation / facilitation / follow-up activities
- Oversees ongoing inspection readiness activities to develop 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
Requirements
- 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
- University degree in life sciences
Benefits
- 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
- …and more!
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