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. 

Job Summary: 

The Senior 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, EMA, and other applicable regulatory bodies. Utilize a broad and diverse background and experience to assist with inspection readiness, intelligence and risk mitigation plans to assure adherence to applicable GxP regulations and guidelines in the conduct of non-clinical and clinical trials, to ensure quality and integrity of generated data, oversight of post-market safety activities, and protection of the rights and welfare of subjects/patients.

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. 

• Develop, implement, and maintain quality assurance policies, procedures, and systems to ensure compliance with GCP/GVP/GLP, ICH guidelines, and regulatory requirements.
• Translate risk factors into clinical quality assurance oversight plans, including internal and external audit strategies and inspection readiness/management strategies.
• Support the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and process/systems, including for-cause and directed activities.
• Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to Health Authorities, business partners and senior management
• Lead vendor quality oversight activities and manage external quality (e.g. quality agreements with CROs, set vendor quality councils, etc.)
• Oversee the continuous improvement and maintenance of an effective inspection management framework supporting clinical trials and pharmacovigilance.
• Provide leadership and oversight for GCP Inspections ensuring effective readiness, preparation, management, and response development and action closure.
• Ensure timely identification, investigation, and resolution of quality issues and non-compliances.
• Collaborate with Clinical Operations, Clinical Development, Global Drug Safety & PV, Clinical Outsourcing, Translational Medicine and other departments to support clinical and non-clinical programs and ensure quality and compliance.
• Act as a primary liaison for Global Product Safety and PV supporting key activities for PSMF compliance, REMS development, and commercial product safety (SMT and PSRC representation).
• Engage with cross functional business partners to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement, drive issue resolution
• Monitor and interpret regulatory trends and changes, and ensure the company's clinical, non-clinical and PV quality systems are updated accordingly.
• Represent the company in interactions with regulatory agencies.
• Develop and deliver training programs to enhance quality awareness and compliance across the organization.
• Prepare and present quality metrics and reports to senior management and other stakeholders.
• Engage and influence in external industry consortiums and benchmark opportunities.

Education:  

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

Required Experience: 

• Minimum 15-20 years Quality experience or relevant BioPharma experience, with demonstrated experience in R&D and R&D Quality roles.
• Extensive knowledge of GCP, ICH guidelines, and global regulatory requirements for appropriate strategy setting, decision making, and quality oversight to ensure BMS complies with regulatory requirements..
• Proven experience in leading and managing quality assurance teams.
• Strong analytical, problem-solving, and decision-making skills.
• Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication.
• Experience with regulatory inspections and interactions with regulatory agencies.
• Strong leadership and organizational skills, with a commitment to fostering a culture of quality and compliance.
• Previous experience dealing with regulatory agencies in policy development, inspections, investigations, and audits.
• Demonstrated ability to work effectively in a matrix environment and drive results through influence as well as direct management.
• Understands the big picture, beyond their own functional area. Enterprise thinker.
• Proven problem-solving skills to prevent and overcome complex process and quality related issues
• Embraces complexity but strives for simplicity. Keen focus on phase appropriate and risk based scientific decision making
• Creates a vision for the future by spotting strategic opportunities for breakthrough performance. Translates the case for change into actionable plans for the organization.
• Demonstrates smart risk-taking and personal resilience when implementing change. Enables others to navigate change with confidence and in sustainable ways.

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. 

We are an Equal Opportunity Employer. 

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