Director, Clinical Quality Assurance

BioNTech•Berkeley Heights, NJ

75d•$202,000 - $247,000

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

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
Fluent in English (Mandarin is a plus)

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

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