Manager, Global Quality Intelligence & Product Quality Complaints (remote)
BioNTech SE
August 11, 2026
Remote friendly (Berkeley Heights, NJ)
United States
Operations
Your Contribution:
- Ensure regional and global compliance as an MAH/Sponsor representative by addressing evolving global regulatory expectations.
- Develop and maintain procedures, training, and quality oversight processes supporting product lifecycle, regulatory surveillance, recalls, and related MAH/Sponsor responsibilities.
- Build and maintain Product Specification Files (PSFs) and ensure 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 products (intake, triage, assessment, investigation, classification, disposition, closure).
- Ensure compliance with global regulatory requirements, internal procedures, and reporting obligations for complaint handling.
- Lead complaint investigations and CAPAs; oversee third-party activities; escalate quality/compliance risks in a timely manner.
- Serve as primary point of contact for PQC activities and collaborate across Quality, Pharmacovigilance, Medical Information, Release Hub, Supply Chain, and external partners.
- Support and represent the organization during inspections and audits for MAH/Sponsor oversight and complaint handling.
- Provide regular updates to leadership on quality metrics, compliance risks, escalations, and achievements.
- Contribute to standardization, globalization, digitalization, and continuous improvement of the Quality Management System.
- Mentor and role model quality, compliance, accountability, and continuous improvement.
A Good Match:
- Degree in Pharmacy, Chemistry, Biology, or related scientific field.
- 5+ years of experience in Quality MAH/Sponsor responsibilities.
- Proven track record in Product Quality Complaint Management, GMP compliance, and regulatory processes.
- Strong knowledge of GMP, ICH Q10, CFR Part 211, and regional/national regulatory requirements.
- Exceptional communication/networking skills; excellent written/verbal English.
- Critical thinking and agility; ability to manage priorities and track/report key projects.
Benefits (as stated): Expected pay range $113,600–$181,600/year + benefits, annual bonus & equity (variable).
Apply: Submit documents via the online application form for the listed locations (New Jersey, Cambridge, Gaithersburg).
- Ensure regional and global compliance as an MAH/Sponsor representative by addressing evolving global regulatory expectations.
- Develop and maintain procedures, training, and quality oversight processes supporting product lifecycle, regulatory surveillance, recalls, and related MAH/Sponsor responsibilities.
- Build and maintain Product Specification Files (PSFs) and ensure 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 products (intake, triage, assessment, investigation, classification, disposition, closure).
- Ensure compliance with global regulatory requirements, internal procedures, and reporting obligations for complaint handling.
- Lead complaint investigations and CAPAs; oversee third-party activities; escalate quality/compliance risks in a timely manner.
- Serve as primary point of contact for PQC activities and collaborate across Quality, Pharmacovigilance, Medical Information, Release Hub, Supply Chain, and external partners.
- Support and represent the organization during inspections and audits for MAH/Sponsor oversight and complaint handling.
- Provide regular updates to leadership on quality metrics, compliance risks, escalations, and achievements.
- Contribute to standardization, globalization, digitalization, and continuous improvement of the Quality Management System.
- Mentor and role model quality, compliance, accountability, and continuous improvement.
A Good Match:
- Degree in Pharmacy, Chemistry, Biology, or related scientific field.
- 5+ years of experience in Quality MAH/Sponsor responsibilities.
- Proven track record in Product Quality Complaint Management, GMP compliance, and regulatory processes.
- Strong knowledge of GMP, ICH Q10, CFR Part 211, and regional/national regulatory requirements.
- Exceptional communication/networking skills; excellent written/verbal English.
- Critical thinking and agility; ability to manage priorities and track/report key projects.
Benefits (as stated): Expected pay range $113,600–$181,600/year + benefits, annual bonus & equity (variable).
Apply: Submit documents via the online application form for the listed locations (New Jersey, Cambridge, Gaithersburg).