Director, Global Quality, US & Americas
About The Position
As Director, Global Quality (US & Americas), you will play a pivotal role in ensuring quality oversight and compliance across the region. This position is integral to BioNTech’s mission of advancing medical science and improving health outcomes worldwide. You’ll act as a key connector between regional teams, global functions, and health authorities, enabling successful product launches and building sustainable, high-performing quality capabilities. In this role, you’ll lead with strategy and precision to strengthen confidence in our operations while fostering collaboration across diverse stakeholders. Your expertise will help shape the future of BioNTech’s quality systems in one of our most critical regions.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, or related field
- 10+ years of experience in Quality/Commercial Compliance within pharmaceutical or biotech industries
- Strong knowledge of FDA regulations and global quality standards
- Proven ability to manage inspections and regulatory interactions effectively
- Demonstrated leadership skills in a matrix environment with multiple stakeholders
- Willingness to travel based on business needs
Nice To Haves
- advanced degree preferred
Responsibilities
- Provide strong governance and oversight of Quality & Compliance activities across the US region
- Review and ensure effective execution of regulatory commitments
- Identify risks and gaps in local quality systems and implement proactive mitigation strategies
- Drive increased transparency, consistency, and accountability in quality processes
- Define, track, and analyze key quality metrics and performance indicators
- Deliver regular updates on regional performance, risks, and escalations to Global Quality leadership
- Ensure timely escalation and resolution of critical compliance issues
- Act as the primary point of contact for cross-functional stakeholders (Regulatory, Medical, Supply Chain, Commercial) within the region
- Foster strong collaboration to ensure aligned and compliant execution of activities
- Provide quality leadership and strategic guidance to regional and functional teams
- Lead regional Quality teams in a matrix environment, driving alignment and performance without direct authority
- Facilitate regular governance and follow-up meetings to track progress and address key challenges
- Build capability and strengthen accountability across the regional network
- Serve as a key interface with Health Authorities, including the FDA
- Support and lead inspection readiness activities and regulatory interactions
- Represent Regional Quality during inspections and audits in partnership with Global Quality
- Ensure quality readiness for product launches in the US and broader region
- Apply lessons learned to improve execution and prevent recurring issues
- Support preparation of emerging markets (America) for future launches
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
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What This Job Offers
Job Type
Full-time
Career Level
Director
