Sr. Director, Quality Control in Abingdon

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.

The Senior Director QC (Milton Park) is responsible for all QC operational activities, focusing on areas related to timely and compliant release to assure timely supply of product. The Senior Director QC will ensure that this work is planned, performed, and reported in an efficient and compliant manner and a key part of the role will be delivering operational excellence. The QC team is responsible for activities that include product testing, in‑processing testing, stability testing and studies to support regulatory applications in support of clinical production and commercial supply.

The Senior Director QC will be responsible for technology transfer of QC assays and validation of test procedures / sites. They will be responsible for setting up and maintaining systems for the QC Laboratories at Milton Park, managing external contract QC testing and running the Quality Control Operations. The Senior Director QC will oversee the routine and non‑routine activities of the QC Laboratories, ensuring that they operate efficiently, drive continuous improvement and support compliant testing applications for marketing approval and commercial supply.

Key responsibilities include:

• 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.
• Develop a program of continuous improvement to deliver and drive operational excellence.
• Represent the QC function at cross functional meetings/forums and deputise for the Senior Director QC as required.
• Management and maintenance of the QC Laboratory including sample management and identification, sending samples to contract testing lab, equipment maintenance and calibration, inventory control, order supplies, periodic review of equipment usage logs.
• Write/review SOPs/summary and trend reports as necessary.
• 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 (techniques such as 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 critical reagents.
• Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Responsible for 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 as well as across other functional groups to communicate QC requirements.
• Ensure the 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.
• QC representative for cross functional meetings / projects with manufacturing, QA, Regulatory Affairs, and external partners.
• Will represent QC during regulatory inspections.

Other responsibilities include troubleshooting of equipment and QC methods, leading assay validation and qualification, and managing technical studies performed with external companies with provision and review of reports.

Qualifications:

• BA or BSc in Chemistry/Biochemistry/Microbiology or other related science.
• 12+ years GLP/GMP experience in a relevant work environment and 5+ years of management experience in a GMP‑regulated environment.
• Good analytical skills and technical experience is a must, preferentially with previous experience in product and/or raw materials testing.
• Computer literacy (including MS Word and Excel).
• Ability to work well with others.
• Effective communication skills.
• Good organizational skills.

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. For more information, please visit www.replimune.com. We are an Equal Opportunity Employer.