Director, Quality Systems

Overview

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.

At Replimune, we live by our values:

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, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

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 010.

The Director, Quality Systems has the opportunity to create influential and collaborative relationships for Quality across the company and will be accountable for but not limited to; training, documentation, vendor management, change control, corrective action preventative action (CAPA), deviation management and quality metrics development and reporting. Managing and maintaining eDMS tools are essential to the role, as is management of the international quality systems team.

• This position is based in our Framingham location and typically has a 5-day on-site expectation.

• Oversee/Manage a compliant and effective Quality System as described in ICH Q10 including the following components:
  • Document Management
  • Training compliance
  • Change Control
  • Deviation Management
  • CAPA
  • 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 elevate 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 along with development and execution of actions focused on risk mitigation. This includes identification of interim controls and influencing stakeholders to drive timely action where mitigation is required and assist with coordinating inspection responses within defined regulatory timelines and generation of the associated CAPA plans.
• Implementing efficiency improvements on a continuous basis and participating 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 and maintenance and business use of electronic quality system tools (Master Control).

• 10 years' experience working in a Quality Assurance or Quality Systems role in the pharmaceutical industry.
• Experience with electronical 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 working effectively in a team-oriented environment

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

Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base…