Associate Director – Clinical Quality Assurance

BioNTech SE

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.

Posted 4/19/2026full-timeCambridge • Massachusetts, New Jersey • 🇺🇸 United StatesSenior💰 $163,000 - $200,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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!

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Strategy implementationinspection managementQuality Agreementsclinical trial risk managementinspection readiness activitiesGCP compliancequality dashboard maintenanceclinical development activitiesnarrative development

Soft Skills

collaborationstakeholder engagementproactive problem-solvingorganizational skillscommunication