Hybrid Director, GMP Quality Assurance

at Disc Medicine

• Job title: Director, GMP Quality Assurance
• Job type: Full Time
• Experience level: Lead
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Watertown, United States

About the role

• Director of GMP Quality Assurance overseeing the Biologics manufacturing pipeline at Disc Medicine. Ensuring quality oversight and compliance for late-stage clinical trials across diverse teams.

Responsibilities

• Provide quality partnership and oversight of Disc Medicine’s Biologics manufacturing, testing, and disposition of products.
• Support ongoing technology transfer of drug product and device manufacturing processes.
• Ensure compliance in Disc Medicine Quality Management System and CDMO manufacturing and testing operations with applicable GMP regulations.
• Collaborate with cross-functional teams to draft, review, and verify documents to Health Authority CMC submissions.
• Develop, implement and approve risk-based quality system oversight related to CDMO manufacturing and testing of combination products.
• Partner closely with internal stakeholders to ensure program alignment and timely delivery of quality milestones.
• Identify and escalate quality risks while driving effective, compliant resolutions.

Requirements

• Bachelor’s Degree in a scientific discipline or related scientific field.
• 12-15 years of progressive Quality Assurance experience, with experience in Technology Transfer, Global Quality Management System design and implementation.
• Hands-on expertise with Combination Products (Device and Biologic) including the ability to develop business and QMS processes, procedures.
• Proven track record for building Quality culture with direct experience in supporting GMP operations.
• Proven track record for working on CMC, development program, quality management review, and vendor joint steering committees.
• Demonstrated experience in all aspects of clinical development of biologics is desirable; development of quality strategy and direct discussions with applicable Health Authorities.
• Self-driven, extraordinarily organized, and have an established track record for building effective working relationships across stakeholder groups.
• Ability to convey complex issues, risks, solutions, and decisions succinctly.
• Ability to travel nationally and internationally (10-20%)

Benefits

• Comprehensive benefits
• Competitive compensation packages
• Flexible work environment