Director, Quality Systems

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. 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.

Responsibilities

Oversee/Manage a compliant and effective Quality System as described in ICH Q10 including 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 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 along with development and execution of actions focused on risk mitigation; 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 (MasterControl)

Requirements

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; 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

Nice to have

Project Management/Operational Excellence experience with Lean, Six Sigma, or both; Continuing education or advanced degree in a biological or pharma industry area

Benefits

Annual performance incentive bonus; New hire equity; Ongoing performance-based equity; Medical, dental, and vision insurance; 401k match; Flexible time off; Paid holidays including year-end shutdown