Manager, Quality Assurance

The role

The Manager of QA provides quality oversight for the Product Complaint program. This role includes investigation resolution for clinical and commercial material complaints and ensuring inspection readiness through audits and procedure management.

What you will do

• Serve as the liaison for the commercial product complaint call center and manage clinical product complaints.
• Ensure product complaints are investigated and resolved in accordance with internal requirements and regulatory expectations.
• Support product compliant reconciliation with the call center and Pharmacovigilance.
• Continuously improve the internal product complaint program.
• Serve as Auditor for internal and external audits.
• Ensure internal and external audit responses and appropriate CAPAs are identified and managed.
• Continuously improve internal and external audit programs.
• Provide support for the initial review, periodic review, and revision of Summit QTAs.
• Write, revise, review and/or approve SOPs and other controlled documents.
• Participate in developing, reporting, reviewing and trending of quality and performance metrics.

Required 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 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 and close quality records in accordance with established timelines.
• 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 expected in all aspects of work.

Benefits

• bonus
• stock
• benefits

About the company

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.