Site Director, Development Quality
Core
Senior leadership role protecting patients and ensuring GMP standards in pharmaceutical development while enabling teams to deliver with pace and confidence.
Role type
Senior leadership pharmaceutical quality director
Builds
Investigational products and comparators for clinical trials
Domain
Pharmaceutical development and GMP compliance
Required skills
GMP leadership, Quality Assurance, pharmaceutical development lifecycle, risk management, team leadership, regulatory submissions, oral solid dosage, inhalation products
Preferred skills
Change management, cross-functional collaboration, talent development, strategic planning
Technologies
GMP, Quality Systems, regulatory frameworks
Responsibilities
Lead the site Quality team and set strategic direction for Development Quality globally. Partner with senior leadership to integrate quality into business decisions. Lead responses to significant compliance issues including recalls and complaints. Sponsor and drive quality improvement initiatives. Ensure high-quality input to development projects and regulatory submissions. Maintain the site's pharmaceutical license and lead regulatory authority interactions.
Seniority
Senior, strategic leadership