Principal Associate II, Quality Systems

About the role

This position provides cross-functional support of GxP activities as they relate to Quality Systems. The role leads the administration, optimization, and continuous improvement of electronic Quality Management Systems (eQMS) to ensure quality processes remain effective, compliant, and inspection ready. It serves as a subject matter expert for Veeva Quality applications and supports MasterControl administration and system governance activities. The 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 Framingham with a typical 4-day on-site expectation.

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.

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.

Skills

• 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 and 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 and ability to work 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.
• Experienced in the use of computer/electronic systems (eQMS, etc.).

Pay

The anticipated base pay range for this role is $134,000–$173,500. The exact base pay offered will depend on various factors, including the selected candidate’s qualifications, skills, and experience, as well as organizational needs. Base pay is only one part of the total compensation package, which also includes eligibility 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 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 versatility in development either alone or combined with a variety of other treatment options.