Director, Quality Control

Replimune – Milton Park, Abingdon‑On‑Thames, England, United Kingdom

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full‑body anti‑tumor response, boldly transforming cancer care because patient’s lives depend on it. We imagine a world where cancer is a curable disease.

At Replimune, we live by our values:

• United: We Collaborate for a Common Goal.
• Audacious: We Are Bold and Innovative.
• Dedicated: We Give Our Full Commitment.
• Candid: We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees we make it personal. With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward‑looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients.

Join us as we reshape the future.

We are looking for a motivated QC Director at our Milton Park site to be part of the QC Leadership team. The successful candidate will have 10+ years GMP experience with at least 3‑4 years of management experience in a GMP‑regulated environment. Good technical knowledge of PCR, HPLC, impurity and cell‑based methods is essential. The position must have knowledge and experience of method transfer/validation.

The Director QC will set up and maintain systems for the QC Laboratories at Milton Park, manage external contract QC testing, oversee routine and non‑routine activities, drive continuous improvement, and support compliant testing for marketing approval and commercial supply. The Director QC will deputize for the Senior Director QC as required and represent the QC department at cross‑functional meetings.

• Recruitment, leadership, and direction of the QC team at Replimune, Milton Park.
• Design and monitor KPIs for all areas of Quality Control at Milton Park and work collaboratively with QC Framingham to ensure KPIs are consistent and effective across sites.
• Represent the QC function at cross‑functional meetings/forums and deputize for the Senior Director QC as required.
• Manage and maintain the QC Laboratory, including sample management and identification, sending samples to contract testing labs, equipment maintenance and calibration, inventory control, ordering supplies, and periodic review of equipment usage logs.
• Write/review SOPs and produce summary and trend reports.
• Establish and maintain procedures for QC testing.
• Manage the QC laboratory set‑up and equipment validation.
• Responsible for the protocol and report generation of assay transfers related to QC tests (e.g., ELISA, bioassays, gel electrophoresis, spectroscopy, PCR).
• Oversee external vendors / contract testing facilities for QC testing needs and provide technical support.
• Responsible for executing stability programs for product and key raw materials.
• Manage the system of critical reagents.
• Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Handle change control and deviations related to QC operations, including assisting with laboratory and OOS, OOT, and lab investigations.
• Author QC regulatory documentation and assist in regulatory audits/inspections as needed.
• Interact within internal and across other functional groups to communicate QC requirements.
• Ensure safe operation of the QC laboratories at the Milton Park site.
• Develop and maintain a culture of continuous improvement within the QC team.
• Develop and maintain KPIs, monitor performance of the QC Laboratory Operational group, and drive demonstrable improvements.
• Represent QC during cross‑functional meetings and projects with manufacturing, QA, Regulatory Affairs, and external partners, and during regulatory inspections.

• Troubleshoot equipment and QC methods.
• Manage/perform assay validation and qualification as necessary.
• Manage technical studies performed with external companies, including provision and review of reports.

• BA or BSc in Chemistry, Biochemistry, Microbiology, or other related science.

• 10+ years GLP/GMP experience in a relevant work…