Job Description

Gaithersburg, US | full time | Job ID: 11511

About the Role:

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.

Your Contribution:

Regional Quality Oversight
• 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

Performance & Reporting
• 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

Cross-Functional Leadership
• 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

Matrix Leadership
• 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

Health Authority Engagement
• 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

Launch Readiness & Expansion
• 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

A Good Match:

• 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

Your benefits and remuneration:

Expected Pay Range: 168,100year to 268,700/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• 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! More details to be shared.

Located in the BioHealth Capital Region near Washington DC and ranked among the top biopharma hubs in the country, Gaithersburg, Maryland offers a unique and diverse cluster across industry, government, and academia for top talent and scientific innovation. As a pivotal player within the life sciences community, Gaithersburg is distinguished by its robust infrastructure and strategic location near the nation’s capital. The city’s strategic significance is amplified by its state-of-the-art manufacturing facilities that cater to the rigorous demands of the life sciences industry; Gaithersburg’s manufacturing sector is defined by advanced technologies and complies with the most stringent regulatory standards, ensuring the production of high-quality pharmaceuticals, biologics, and medical devices. In the coming years, Gaithersburg will continue to be a vital contributor to the future of medical science and technology.

Apply now - We look forward to your application!

Apply for our Gaithersburg location and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.