Director, R&D Quality - Replimune, Inc.

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, caregivers and themselves .

Join us, as we reshape the future.

Position Summary:

The Director of R&D Quality is responsible for contributing to the development, implementation and maintenance of Quality Assurance systems and activities for Replimune’s R&D activities. Ensures all relevant quality and regulatory requirements are met for good clinical practices (GCP), good laboratory practices (GLP), good pharmacovigilance practices (GVP) and clinical site and vendor compliance with GxP regulations issued by FDA, MHRA and other applicable regulatory bodies. Utilize auditing experience to assist with inspection readiness, intelligence and risk mitigation plans to assure adherence to applicable GxP regulations and guidelines in the conduct of clinical trials, to ensure quality and integrity of generated data, and protection of the rights and welfare of subjects/patients.

Key responsibilities:

• Continuously assess compliance status of clinical programs/studies.
• Partner with senior members of clinical and medical staff to develop plans for quality oversight of GCP and GVP activities.
• Maintain strong relationships with multiple internal and external team members and cross functional groups.
• Input into audit plans for all ongoing clinical studies and support auditing of clinical sites, GCP/GLP/GVP vendors, internal systems as well as clinical, data collection and processing activities.
• Provide quality oversight to GCP/GLP/GVP vendors through vendor qualification and other appropriate quality oversight mechanisms as applicableProvide leadership for study team inspection readiness, and strongly contribute to GCP/GLP/GVP regulatory inspections globally.
• Ensure Replimune inspection readiness and support third parties (clinical sites and vendors) during health authority inspections.
• Oversee/Support the development of SOPs for internal GCP/GLP/GVP activities as well as monitoring and ensuring continuous improvement of these procedures/processes.
• Input into planning of audits of systems and processes needed to support regulatory submissions. Provide required Quality contribution to clinical, nonclinical and drug safety sections of regulatory submissions.
• Provide QA contribution, advice and review if required for clinical study protocols and protocol amendments, investigator brochures, informed consent forms, final clinical study reports, DSURs and the like. Specific review requirements are designated per departmental SOPs.
• Assist with or provide GCP/GLP/GVP training for Replimune employees as appropriate.
• Oversee investigations of GCP/GLP/GVP related quality issues, deviations, and root cause investigations. Collaborate with GCP/GLP/GVP functions to identify, assess, and determine effectiveness of CAPAs and manage and approve completion of CAPAs.
• Conduct internal compliance metrics analyses and risk assessments related to functional area responsibilities and report to management as appropriate.
• Provide support for Quality Management Review.

 Other responsibilities

• Other duties as assigned.

Educational requirements:

• BS or equivalent; advanced degree a plus.
• PhD may substitute for 3 years’ experience

 Experience and skill requirements:

• 12-15 years’ experience in clinical quality assurance or clinical operations background, in a regulated biotechnology, pharmaceutical or diagnostics industry environment.
• Appropriate GCP/GLP/GVP training (experience in all disciplines is not required and can be taught)
• Knowledge of FDA, EMA and MHRA regulations and guidelines regarding GCP, GLP and GVP activities
• Excellent verbal and written communication skills
• Knowledge of QMS and CAPA related processes and systems is required
• Ability to work across GCP/GLP/GVP functional areas and foster a collaborative culture of Clinical quality within the organization
• Knowledge of Clinical Risk Management and Analytics Software a plus
• Experience with NDA and/or BLA submissions and Inspection readiness for Sponsors, clinical sites and vendors is strongly desired
• Auditing Certifications a plus
• Management experience a plus

This position can be based either in our Woburn office or be a remote role

• Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require.

About Replimune 
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. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

Replimune is an equal opportunity employer.