Global Quality & PQC Manager — GMP MAH Oversight

Xtalks; Berkeley Heights (NJ); On-site; USD 114,000 - 182,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

401(K) Plan with Company Match

Tuition Reimbursement

Job summary

BioNTech US in Gaithersburg seeks a Manager for Global Quality Intelligence & Product Quality Complaints to establish and improve a global QA framework, ensuring GMP compliance for MAH/Sponsor activities across the pharmaceutical footprint.

You will oversee the end-to-end Product Quality Complaint lifecycle and collaborate with QA, Regulatory, Pharmacovigilance, and others to ensure patient safety and regulatory adherence.

Qualifications

• 5+ years of Quality MAH/Sponsor experience.
• Proven track record in Product Quality Complaint Management and GMP compliance.
• Strong knowledge of GMP guidelines, ICH Q10, CFR Part 211 and regulatory requirements.
• Excellent written and verbal English communication.

Responsibilities

• Establish and maintain a global QA oversight framework for MAH/Sponsor activities.
• Lead end-to-end Product Quality Complaint lifecycle for clinical and commercial products.
• Drive investigations, CAPAs, and timely escalation of quality risks.
• Coordinate with QA, Pharmacovigilance, Medical Information, Release Hub, and Supply Chain.
• Support inspections and audits and provide leadership updates on metrics.

Skills

Quality MAH/Sponsor responsibilities

Product Quality Complaint Management

GMP compliance

Regulatory processes

Excellent English communication

Education

Degree in Pharmacy

Chemistry

Biology

Job description

BioNTech US in Gaithersburg seeks a Manager for Global Quality Intelligence & Product Quality Complaints to establish and improve a global QA framework, ensuring GMP compliance for MAH/Sponsor activities across the pharmaceutical footprint.

You will oversee the end-to-end Product Quality Complaint lifecycle and collaborate with QA, Regulatory, Pharmacovigilance, and others to ensure patient safety and regulatory adherence.