Cambridge, US | full time | Job ID: 11194

About the role:

The Manager Quality Intelligence & Strategy is responsible for establishing, implementing, and continuously improving a comprehensive Global Quality Assurance (QA) oversight framework to ensure robust GMP/GDP compliance for Marketing Authorization Holder (MAH) and Sponsor‑related activities across the global pharmaceutical footprint. This role drives strategic QA execution across multiple regions and ensures alignment with regulatory expectations, operational excellence, and sustainable quality systems. This role supports improvement projects such as notification management from manufacturing network, Regulatory guidance surveillance and continuous improvement of GMP escalations process.

Your Contribution:

• Serve as Manager, Quality Intelligence & Strategy with a focus on GMP and compliance processes to fulfill MAH/Sponsor responsibilities. This includes designing, maintaining, and optimizing the process landscape to support compliance and operational excellence.
• Support discussions and decision making with strategic partners on complex GMP and compliance topics. Responsibilities include coordinating and preparing comprehensive documentation and organizing/assisting Quality forums and governance committees to ensure alignment and collaboration.
• Provide clear guidance to cross functional stakeholders, promoting a strong Quality culture across the organization. This includes effective communication, advisory support to peers, and cross network collaboration to achieve company objectives while maintaining compliance.
• Contribute to the continuous improvement of the Pharmaceutical Quality System in accordance with EU GMP Guide Chapter 1, ICH Q10, and applicable regional/national regulations.
• Ensure regional and global compliance in the capacity of an MAH/Sponsor representative by addressing evolving global regulatory expectations.
• Implement new processes to strengthen MAH/Sponsor oversight and improve the visualization, transparency, and sharing of key Quality information with stakeholders.
• Lead and support Quality Board processes, ensuring effective evaluation of Quality metrics, trends, and compliance related data to facilitate informed decision making and continuous improvement.
• Proactively maintain, analyze, and report relevant Quality metrics, identifying risks and implementing mitigation strategies to ensure compliance and operational efficiency.
• Support inspections and audits related to MAH/Sponsor responsibilities, including preparation, coordination, and follow up activities. Ensure inspection readiness and provide subject matter expertise during regulatory interactions.

A good match:

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 5 years of experience in Quality Assurance, GMP compliance, and regulatory processes within the pharmaceutical industry.
• Demonstrated experience managing MAH/Sponsor responsibilities and Quality Management System (QMS) frameworks.
• Strong knowledge of GMP guidelines, ICH Q10, 21 CFR Part 211, and relevant regional/national regulatory requirements.
• Exceptional communication and collaboration skills with the ability to influence and work effectively across teams and stakeholders.
• Excellent written and verbal communication skills in English.
• Strong analytical and problem solving skills with the ability to navigate complex compliance challenges and drive solutions.

Preferred Qualifications:

• Advanced degrees (MSc, PhD) are preferred.

Expected Pay Range: $113,600 - $181,600/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.

Your Benefits:

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.

Berkeley Heights is New Jersey's growing hub within the life sciences industry and has already demonstrated the state’s commitment to innovation, collaboration, and excellence within the field. New Jersey's integrated approach to biotechnology and pharmaceuticals harmonizes academic rigor, industrial capability, and government support to create thriving conditions for a growing ecosystem. Cultivating an environment that seamlessly integrates cutting-edge research, robust manufacturing capabilities, and a dynamic business landscape, New Jersey has become a powerhouse in pharmaceuticals, biotechnology, and medical technology. As this region of New Jersey continues to develop, it stands ready to shape the future of medical science and technology, driving progress and improving health outcomes worldwide.

Apply now - We look forward to your application!

Apply for our Cambridge, US 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 ‘Hire Right’. You will be informed accordingly by your BioNTech-Recruiter.