Quality Manager Jobs

About The Position

Requirements

• Degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Extensive experience (5+ years) in Quality MAH/Sponsor responsibilities
• Proven track record of Product Quality Complaint Management, GMP compliance, and regulatory processes within the pharmaceutical industry.
• Strong knowledge of GMP guidelines, ICH Q10, CFR Part 211 and regional/national regulatory requirements.
• Exceptional communication and networking skills to foster collaboration across teams and stakeholders.
• Excellent written and verbal communication skills in English.
• Proven track record of critical thinking and agility. This includes the ability to manage priorities, track progress of key projects, and provide updates to leadership, as required.

Responsibilities

• Ensure regional and global compliance in the capacity of an MAH/Sponsor representative by addressing evolving global regulatory expectations.
• Contribute to the development and maintenance of procedures, training, and quality oversight processes supporting product lifecycle, regulatory surveillance, recalls, and related MAH/Sponsor responsibilities.
• Build and maintain processes (e.g. Product Specification Files (PSFs)) ensuring compliance with product‑relevant regulatory documentation (BLAs, MAAs, IMPDs, etc).
• Manage the end-to-end lifecycle of Product Quality Complaints (PQC) for clinical trial materials and commercial pharmaceutical products, ensuring effective intake, triage, assessment, investigation, classification, disposition, and closure.
• Ensure compliance with global regulatory requirements, internal procedures, and reporting obligations related to complaint handling.
• Lead complaint investigations and CAPAs, oversee third-party activities, and drive the timely escalation of quality and compliance risks.
• Serve as the primary point of contact for PQC-related activities, fostering effective collaboration across Quality, Pharmacovigilance, Medical Information, Release Hub, Supply Chain, and external partners.
• Support and represent the organization during inspections and audits related to MAH/Sponsor oversight and complaint handling, providing expertise, coordinating responses, and ensuring timely resolution of observations.
• Provide regular updates to leadership on quality metrics, compliance risks, escalations, and key achievements to support informed decision-making.
• Contribute to the standardization, globalization, digitalization, and continuous improvement of the BioNTech Quality Management System and associated processes.
• Act as a mentor and role model, promoting a culture of quality, compliance, accountability, and continuous improvement.
• Perform additional duties and responsibilities as required to support departmental and business objectives.

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