Manager Quality Intelligence & Strategy

BioNTech•Cambridge, MA

10d

About The Position

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.

Requirements

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.

Nice To Haves

Advanced degrees (MSc, PhD) are preferred.

Responsibilities

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.

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