Manager, Global Quality Intelligence – Product Quality Complaints

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🏖️ New Jersey, Maryland – Remote

🏖️ New Jersey – Remote 🦀 Maryland – Remote

💵 $113.6k - $181.6k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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BioNTech SE

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

BioNTech SE is a global immunotherapy powerhouse focused on translating scientific research into innovative therapies and vaccines aimed at improving health worldwide. Founded by scientists and physicians, BioNTech is committed to developing targeted cancer treatments and vaccines for infectious diseases, leveraging advanced mRNA technology and other novel therapeutic modalities. The company integrates rigorous scientific principles with operational excellence to create therapies that enhance life expectancy and quality of care for patients suffering from serious conditions, including cancer and various infectious diseases.

📋 Description

• Establish, implement, and continuously improve a comprehensive Global Quality Assurance oversight framework for MAH and Sponsor activities • Drive oversight, execution, and continuous improvement of the end-to-end complaint handling process for clinical trial materials and commercial pharmaceutical products • Address evolving global regulatory expectations as an MAH/Sponsor representative • Develop and maintain procedures, training, and quality oversight processes supporting product lifecycle, regulatory surveillance, recalls, and MAH/Sponsor responsibilities • Build and maintain Product Specification File processes and ensure compliance with product-relevant regulatory documentation • Manage Product Quality Complaint intake, triage, assessment, investigation, classification, disposition, and closure • Ensure compliance with global regulatory requirements, internal procedures, and complaint-handling reporting obligations • Lead complaint investigations and CAPAs, oversee third-party activities, and escalate quality and compliance risks • Serve as primary point of contact for PQC-related activities across internal functions and external partners • Support and represent the organization during inspections and audits • Provide leadership updates on quality metrics, compliance risks, escalations, and achievements • Contribute to standardization, globalization, digitalization, and continuous improvement of the BioNTech Quality Management System • Mentor and role-model a culture of quality, compliance, accountability, and continuous improvement • Perform additional duties supporting departmental and business objectives

🎯 Requirements

• Degree in Pharmacy, Chemistry, Biology, or a related scientific field • 5+ years of experience 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 • Excellent written and verbal communication skills in English • Proven critical thinking and agility • Ability to manage priorities, track progress of key projects, and provide leadership updates • Ability to work in the listed US locations • Background check required as part of the recruitment process

🏖️ 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 • Annual bonus & equity • Background check conducted as part of the recruitment process