Director of Quality
Core
Lead Commercial Quality Assurance and Quality Control activities for a new pharmaceutical manufacturing facility, ensuring cGMP compliance and regulatory approval for fast-dissolve oral dosage forms.
Role type
Senior leadership quality director (pharmaceutical manufacturing)
Builds
Commercial manufacturing of Zydis® fast-dissolve oral dosage forms
Domain
Pharmaceutical manufacturing / Consumer Health
Required skills
cGMP compliance, Quality Management Systems (QMS) leadership, FDA/HPFBI inspection management, deviation and CAPA management, strategic safety leadership, regulatory submission documentation, process improvement, trend analysis
Preferred skills
Catalent leadership program experience (NGGL, GOLD, LEAD Now, GM Excellence, GROW)
Technologies
Microsoft Office Suite (Outlook, Excel, Access, Word)
Responsibilities
Oversee and coordinate planning, implementation, and maintenance of the Quality Management System; Identify and achieve strategies for product quality and cGMP compliance; Lead implementation and improvement of QMS; Review and approve documentation for regulatory submissions; Ensure effective completion and follow-up of deviations and CAPAs; Collaborate with operations to drive systematic process improvements; Monitor and participate in Quality Trend programs and analysis; Champion a safety-first culture using the STAR method.
Seniority
Director, strategic leadership and operational oversight
