Executive Director of GMP Quality Assurance, Small Molecules - Remote

Overview

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.

In Short

• Setting quality strategy and driving Quality deliverables for small molecule programs.
• Representing Quality on CMC and development program teams.
• Ensuring compliance oversight of manufacturing and supply chain operations.
• Reviewing analytical control strategies from IND through commercialization.
• Collaborating with stakeholders to make science-driven decisions.
• Applying knowledge of US and ex-US regulations for small molecules.
• Fostering a positive workplace culture focused on collaboration.
• 20-30% travel required.
• Performing other business needs as identified by the manager.

Requirements

• BA/BS required; advanced degree a plus.
• 15 years of applicable GMP quality operations experience required.
• Proven track record in building Quality culture and leading Quality Assurance operations.
• Experience developing business processes guiding manufacturing and QC testing.
• Proven track record in CMC, development programs, and vendor management.

Benefits

• Comprehensive benefits and competitive compensation packages.
• Flexible work environment.