Manager, Quality Assurance

Summit Therapeutics•Princeton, NJ

19d

About The Position

The Manager of Quality Assurance reports to the Director of QA and provides quality oversight for Summit’s Product Complaint program, including investigation and resolution of complaints associated with clinical and commercial material. The role also helps ensure Summit departments and systems are inspection ready through internal and external audits, inspection-readiness support, and authoring and updating internal procedures and Quality Technical Agreements (QTAs). Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life, increasing potential duration of life, and addressing serious unmet medical needs. The company has global Phase 3 clinical studies in non-small cell lung cancer and colorectal cancer. Summit is headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland.

Requirements

Bachelor’s degree in chemistry, biochemistry, biotechnology, or another 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 internal and external audits.
Experience reviewing and approving QTAs.
Demonstrated ability to work within an eQMS to manage and close quality records according to established timelines.
Experience working with CMOs.
Excellent oral and written communication skills.
Ability to work in a fast-paced environment and efficiently manage projects and timelines.
Ability to work individually and within a team while balancing priorities.
Attention to detail, accuracy, and thoroughness in all aspects of work.
Self-motivated, with a strong sense of work ethic.

Responsibilities

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 complaint reconciliation with the call center and Pharmacovigilance.
Continuously improve the internal product complaint program in accordance with applicable laws and regulations.
Serve as an auditor for internal and external audits.
Ensure audit responses and appropriate CAPAs are identified and managed through resolution in a timely manner, and that deliverables are met.
Continuously improve internal and external audit programs to remain current with applicable laws and regulations.
Support the initial review, periodic 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 in a timely manner, management is notified, and deliverables are met.
Participate in developing, reporting, reviewing, and trending quality and performance metrics, including in support of Annual Product Reviews (APRs).
Support GMP inspection-readiness activities.
Perform other duties as assigned.