Director, Quality Systems

About the role

Reporting to the Senior Director, Quality Assurance, the Director, Quality Systems supports the development and implementation of Replimune quality systems to ensure compliance with US and international regulations, laws, and guidelines including ICH Q10. This position is based in our Framingham location and typically has a 5-day on-site expectation.

Responsibilities

• Oversee and manage a compliant and effective Quality System as described in ICH Q10, including:
  • Document Management
  • Training compliance
  • Change Control
  • Deviation Management
  • CAPA (Corrective Action Preventative Action)
  • Quality Metrics Reporting and Trending
• Monitor and report to management on the quality system health.
• Drive quality system initiatives and improvement activities while partnering across functions and sites.
• Provide leadership and guidance to escalate quality system issues to all levels of the organization to ensure compliance with industry expectations.
• Provide leadership to the quality systems staff to ensure effective and consistent customer service to the business.
• Assist with inspection readiness activities, including reporting and escalating inspection risks, developing and executing actions focused on risk mitigation, coordinating inspection responses within defined regulatory timelines, and generating associated CAPA plans.
• Implement efficiency improvements on a continuous basis and participate in site projects and initiatives.
• Facilitate training of functional areas and develop appropriate training for personnel involved in the execution of Quality System processes.
• Oversee implementation, validation, maintenance, and business use of electronic quality system tools (MasterControl).

Requirements

• 10 years' experience working in a Quality Assurance or Quality Systems role in the pharmaceutical industry.
• Experience with electronic documentation systems.
• Experience with inspection management.
• Project Management/Operational Excellence experience with Lean, Six Sigma, or both desirable.
• Experience working cross-functionally across multiple sites and/or time zones.
• Good verbal and written communication skills to establish rapport and develop relationships with key stakeholders.
• Good conflict management and negotiation skills.
• Proven ability to work independently as well as collaborate with peers and work effectively in a team-oriented environment.

Qualifications

• Bachelor's degree or equivalent required.
• Continuing education or advanced degree in a biological or pharma industry area preferred.

Pay

The anticipated base pay range for this role is $191,500-$247,500. The exact base pay offered will depend on various factors, including but not limited to the selected candidate’s unique set of qualifications, skills, and experience. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.

Benefits

• Medical, dental, and vision insurance.
• 401k match.
• Flexible time off.
• Paid holidays including year-end shutdown.

About Replimune

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 patients' lives depend on it. At Replimune, we live by our values: United, Audacious, Dedicated, and Candid. 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, a strong and evolving culture, and a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact the lives of patients, caregivers, and themselves.

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.