QA Manager, Product Complaints & Internal Audits

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

Job summary

Summit Therapeutics is seeking a Manager of QA to oversee the product complaint program for both clinical and commercial materials. You will drive investigations, ensure regulatory alignment, and lead internal and external audits while maintaining inspection readiness.

You will manage QTAs, author SOPs, and collaborate with CMOs and Pharmacovigilance. A strong background in GMP/GDP and eQMS is essential in a fast-paced biopharma setting in the United States.

Qualifications

• Bachelor’s degree in chemistry, biochemistry, biotechnology, or 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 GMP/GDP regulations governing clinical and commercial biologics.
• Experience serving as an auditor in both internal and external audits.
• Experience reviewing and approving QTAs.
• Demonstrated ability working within an eQMS to manage quality records.
• Experience working with CMOs.
• Excellent communication skills both oral and written.
• Ability to work in a fast paced environment and efficiently manage projects and timelines.
• Experience working individually and within a team while balancing priorities.
• Attention to detail, accuracy, and thoroughness.

Responsibilities

• Serve as the liaison for our commercial product complaint call center and also manage clinical product complaints.
• Ensure product complaints are investigated and resolved, in accordance with internal requirements and regulatory expectations.
• Support product complaint reconciliation with the call center and Pharmacovigilance.
• Continuously improve the internal product complaint program in accordance with applicable laws and regulations.
• Serve as Auditor for internal audits and external audits.
• Ensure internal and external audit responses and CAPAs are identified and managed to resolution.
• Continuously improve internal and external audit programs to stay current with laws and regulations.
• Provide support for the review and revision of Summit QTAs.
• Write, revise, review and/or approve SOPs and other controlled documents.
• Ensure issues are identified and managed through resolution with timely notification and deliverables.
• Participate in developing, reporting, reviewing and trending of quality and performance metrics (APR support).
• Support GMP inspection readiness activities.
• All other duties as assigned.

Skills

Quality Assurance

Product Complaints

Auditing

GMP/GDP Knowledge

eQMS

CMOs

Regulatory Knowledge

Communication

Project Management

Education

Bachelor’s degree in life sciences

Tools

eQMS software

Job description

Summit Therapeutics is seeking a Manager of QA to oversee the product complaint program for both clinical and commercial materials. You will drive investigations, ensure regulatory alignment, and lead internal and external audits while maintaining inspection readiness.

You will manage QTAs, author SOPs, and collaborate with CMOs and Pharmacovigilance. A strong background in GMP/GDP and eQMS is essential in a fast-paced biopharma setting in the United States.