Director / Senior Director, Marketing Operations
Cogent Biosciences
Vault
Director/Senior Director, Quality Systems and GxP Compliance
Scholar Rock
full-time
Posted on:
Origin: • 🇺🇸 United States • Massachusetts
Visit company websiteJob Level
Senior
Tech Stack
Vault
About the role
- Serve as the Quality Lead for Quality Systems and Compliance operations across the company and manage quality and compliance guidance to the quality function.
- Oversee and manage GxP Training, Document control, and QMS GxP operations—including change controls, deviations, CAPAs, complaints, audit records, and supplier management activities.
- Track and manage the lifecycle of quality system records to uphold the integrity and compliance of Scholar Rock’s Quality system.
- Ensure timely intake and triage of product complaints, accurate complaint documentation, timely escalation, and proper reconciliation with related systems and departments.
- Assign and manage GxP training via training system, monitor compliance, and generate training completion reports, as needed.
- Participate in validation efforts for new or updated GxP IT systems through review of documentation, execution of test scripts, and supporting change controls as needed.
- Compile and provide metrics related to Quality management system and suppliers for periodic Quality management review meetings.
- Implement and oversee Scholar Rock’s internal audit program.
- Facilitate continuous improvement initiatives to transform and maintain compliance, improving QMS business process efficiency.
- Support inspection readiness activities, as needed.
- Support regulatory submissions including but not limited to annual reports, IND/CTA updates, and/or marketing authorizations.
- Lead and manage the Quality Systems and Compliance team, including direct reports.
- Collaborate with the Head of Quality and site leadership to ensure alignment with corporate goals, customer expectations, and regulatory obligations (FDA, EU, and other global regulators).
Requirements
- BS/MS degree in a scientific discipline
- 10+ years of experience in the pharmaceutical/biotech industry, with 5–7 years in leadership roles within Quality or Quality related functions.
- Deep understanding and current knowledge of all relevant GxP and Quality System requirements (US, EU) for pharmaceutical and biotech, manufacturing and related activities.
- Experience leading and managing regulatory inspections and interfacing with Global Health Authorities.
- Demonstrated understanding of electronic Quality Management Systems, Document Management Systems, and Learning Management Systems.
- Hands-on experience with systems such as Veeva Vault is preferred.
- Highly proactive, decisive, and capable of independently managing key initiatives.
