Executive Director, GMP Quality Assurance, Small Molecules

Disc Medicine

303d

About The Position

Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA. The position of the Executive Director of GMP Quality Assurance, Small Molecules is critical to enable the rapidly growing company portfolio. This role reports to the Senior Vice President of Quality and serves as the Quality leader for Disc's small molecule programs. This position has visibility to the development teams, CMC teams, and executive leadership with meaningful opportunities for professional development and career growth.

Requirements

• BA/BS required; advanced degree a plus.
• >15 years of applicable GMP quality operations experience required unless the candidate has advanced degrees/certification.
• Proven track record for building Quality culture and leading Quality Assurance operations to enable GMP operations in small molecules, including but not limited to quality agreement negotiations, vendor management, complex investigations, GMP change management, and inspection readiness, and leading pre-approval inspections.
• Demonstrated experience developing business processes and procedures that guide manufacturing, QC testing, and supply chain from an operational and quality perspective.
• Proven track record for working on CMC, development programs, quality management review, and vendor joint steering committees.

Responsibilities

• Setting quality strategy and driving Quality deliverables to ensure phase-appropriate cGMP manufacture, testing, and supply for Disc's small molecule programs.
• Represent Quality on CMC, development program, and cross-functional leadership teams internal to Disc and third-party GMP vendors.
• Ensure compliance oversight of manufacturing, analytical, and supply chain operations at external vendors, including establishing quality agreements, guiding investigations, CAPAs, deviations, change controls, and ensuring inspection readiness.
• Review of analytical control strategies to support programs from IND through commercialization, including but not limited to method lifecycle management, critical reagents, and reference standards program, ICH stability program, specifications, and data trending oversight.
• Collaborate with Quality, internal, and external Disc Medicine stakeholders to make science-driven, phase-appropriate, risk-based decisions and proactively identify gaps and design mitigation strategies.
• Application of in-depth knowledge and understanding of current, applicable US and ex-US regulations/guidelines for small molecule products.
• Foster a positive workplace culture that prioritizes collaboration, ensures accountability, and a commitment to continuous improvement.
• Perform any other business needs identified by their manager.

Benefits

• Comprehensive benefits
• Competitive compensation packages
• Flexible work environment

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Bachelor's degree