Summary of job description:

This position provides cross-functional support of GxP activities as they relate to Quality Systems. This position leads the administration, optimization, and continuous improvement of electronic Quality Management Systems (eQMS) to ensure quality processes remain effective, compliant, and inspection ready. The role serves as a subject matter expert for Veeva Quality applications and supports MasterControl administration and system governance activities.

This position reports to the Director, Quality Systems and requires extensive experience in GxP compliance, electronic quality systems administration, regulatory requirements, and cross-functional collaboration. The individual works independently to ensure quality system processes, electronic workflows, and system administration activities are maintained in compliance with applicable global regulations and company requirements.
• This position is based in our Framingham location and typically has a 4-day on-site expectation.

Key responsibilities:
• Demonstrate advanced technical knowledge and independent execution of Quality Systems assignments and projects.
• Lead and manage Quality Systems process improvement and remediation initiatives.
• Serve as Quality Systems representative on multiple GxP projects.
• Support Regulatory Inspection activities and inspection readiness initiatives.
• Demonstrate advanced knowledge of FDA, EU, ICH, and applicable GxP regulatory requirements.
• Author, review and approve Quality documentation including SOPs, Work Instructions, and Quality Reports.
• Generate, analyze, and report Quality metrics and KPIs to support compliance and management review activities.
• Act as a Quality Systems subject matter expert and provide guidance to stakeholders across the organization.
• Support day-to-day Quality Systems operations for multiple sites and internal customers.
• Lead continuous improvement initiatives focused on Quality Systems and electronic Quality platforms.
• Manage relationships and activities associated with Quality Systems vendors.
• Apply regulatory requirements and industry best practices to ensure compliance of Quality System processes.
• Serve as system administrator and subject matter expert for Veeva Quality applications, including user access management, workflow support, troubleshooting, reporting, dashboard development, system configuration support, and compliance oversight.
• Support administration and governance activities within MasterControl, including document control workflows, user access, reporting, and system maintenance activities.
• Lead and support implementation, validation, enhancement, and lifecycle management activities for Quality Systems applications and modules.
• Create and modify user groups, roles, permissions, and system assignments as required.
• Oversee document lifecycle activities including creation, revision, approval, periodic review, archival, and retirement.
• Support document archival processes and controlled record management.
• Participate in and support internal and external audits as Quality Systems SME.
• Provide guidance to stakeholders regarding GxP quality documentation and system-related activities.
• Collaborate cross-functionally to support Replimune's overall success.
• Perform tasks independently with minimal supervision.
• Act as authorized delegate to the Director, Quality Systems as assigned.

Educational requirements:
• Bachelor's degree with practical experience in a regulated manufacturing environment or equivalent experience. Advanced degree preferred.
• Minimum of 7 years of relevant experience in pharmaceutical, biotechnology, biologics, gene therapy, or related regulated industries.
• Extensive experience administering Veeva Quality applications and electronic Quality Management Systems required.
• Experience administering MasterControl preferred.
• Experience supporting commercial GMP manufacturing operations preferred.
• Experience leading cross-functional Quality Systems initiatives preferred.

Experience and Skill Requirement:
• Highly motivated individual with excellent time management skills.
• Demonstrated experience supporting system implementations, upgrades, validation, and continuous improvement activities.
• Strong understanding of electronic quality system controls, data integrity principles, and GxP compliance requirements.
• Ability to influence stakeholders and lead Quality Systems initiatives across functional areas without direct authority.
• Strong collaboration, organizational skills with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail.
• Ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
• Strong interpersonal skills/working in a collaborative environment.
• Flexible and able to deal with ambiguity.
• Strong problem-solving skills.
• Proficient in Microsoft suite (Word, Excel, PowerPoint, Access, and Outlook).
• Excellent written and oral communication skills.
• Ethical, self-motivated, and self-directed.
• Experient in the use of computer/electronic systems (eQMS, etc.)

Salary Range

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 pay range is $134,000-173,500,000. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate's unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.

At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.