Quality R&D Operations Drug Substance Director

Responsibilities

• Lead quality oversight for drug substance development activities, ensuring compliance with current Good Manufacturing Practices and regulatory expectations.
• Own inspection readiness and respond to regulatory questions and observations with timely, clear technical responses.
• Manage a team of quality and compliance professionals.
• Set objectives, coach, and develop people to build capability and resilience.
• Drive quality systems and processes for R&D drug substance workstreams, including change control, deviation management, CAPA, and risk assessments.
• Support supplier and contract manufacturing oversight, audits, and qualification for drug substance-related activities.
• Partner with cross-functional teams to enable product development milestones and timely release of clinical materials.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline.
• 10 or more years of experience in Quality roles in a highly regulated environment (EMA/ FDA/ MHRA).
• 5 years or more of experience in quality management roles for manufacturing operations.
• 8 or more years of experience in pharmaceutical quality, R&D quality, or related roles.
• Experience with cGMP and US regulatory requirements (FDA) in a development or manufacturing environment.
• Prior experience in inspection readiness and regulatory inspections.
• 5 or more years leading direct reports, including coaching and performance management.
• Experience working with third-party suppliers or contract manufacturing organizations.