Director, Global Quality

BioNTech SE

Director of Global Quality ensuring compliance and strategic oversight in the US & Americas for BioNTech. Leading cross-functional collaboration and quality governance to impact medical science and health outcomes.

Posted 6/19/2026full-timeGaithersburg • Maryland • 🇺🇸 United StatesLead💰 $168,100 - $268,700 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degree preferred
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

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

ATS Keywords

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Hard Skills & Tools

regulatory compliancequality metrics analysisrisk managementinspection readinessaudit managementperformance indicatorsquality systemsstrategic guidanceproactive mitigation strategiescross-functional collaboration

Soft Skills

leadershipcommunicationcollaborationaccountabilityproblem-solvingstakeholder managementorganizational skillsadaptabilityinfluencingteam building