QA Manager: Product Complaints & Audits (Biotech)

Summit Therapeutics, Inc.; Princeton (NJ); On-site; USD 139,000 - 163,000; Full time

Job summary

Summit Therapeutics Inc. in New Jersey is seeking a Manager of QA to oversee the Product Complaint program and audit readiness. You will lead investigations, ensure regulatory compliance, and author/update SOPs and QTAs for both clinical and commercial materials.

The role requires 5+ years of experience, strong GMP knowledge, and excellence in communication. Office-based role with emphasis on rapid corrective actions and continuous improvement.

Qualifications

• Bachelor’s degree in chemistry, biochemistry, biotechnology, or other related life science discipline.
• Minimum of 5+ years of relevant experience.
• Experience managing product complaints.
• Strong knowledge of FDA, EMA, MHRA, ICH, PIC/S and international GMP/GDP regulations.
• Experience serving as an auditor in internal and external audits.
• Experience reviewing and approving QTAs.
• Experience working with CMOs.
• Excellent oral and written communication skills.

Responsibilities

• Serve as liaison for our product complaint call center and manage clinical product complaints.
• Ensure complaints are investigated and resolved per internal requirements and regulatory expectations.
• Support product complaint reconciliation with call center and Pharmacovigilance.
• Improve internal product complaint program in line with laws and regulations.
• Serve as Auditor for internal and external audits.
• Ensure audit responses and CAPAs are identified and resolved timely.

Skills

Quality management

Auditing

Regulatory compliance

Process improvement

Project management

Education

Bachelor’s degree in chemistry/biochemistry/biotechnology or related life science

Tools

eQMS

QTAs

Job description

Summit Therapeutics Inc. in New Jersey is seeking a Manager of QA to oversee the Product Complaint program and audit readiness. You will lead investigations, ensure regulatory compliance, and author/update SOPs and QTAs for both clinical and commercial materials.

The role requires 5+ years of experience, strong GMP knowledge, and excellence in communication. Office-based role with emphasis on rapid corrective actions and continuous improvement.