Director, Quality

About This Role

This senior leadership role focuses on global, site, and department leadership within the Clinical and Specialty Services division. The Director of Quality will drive quality strategy, ensure regulatory compliance, and foster a culture of operational excellence in a fast-paced, customer-focused organization.

Responsibilities

• Create and implement Business Unit quality strategy, global quality policies, and BU quality process harmonization with the BU VP Quality and other CSS Quality Directors
• Create and sustain a site culture of Safety, Quality Performance, Operational Excellence, Continuous Improvement, Error Reduction, Regulatory Compliance, and sound fiscal responsibility as a member of the Site Leadership Team
• Lead the development of site Quality Objectives, site Quality Plans, Quality Management Reviews, etc.
• Oversee and execute all Performance Management Program (PMP) actions for the site Quality Assurance department, including professional development counseling, informal and formal performance appraisals and feedback, and talent development/success planning
• Conduct internal investigations on cGMP issues, trends, and customer complaints
• Review and approve GMP documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch Records for cGMP compliance and clarity
• Ensure process integration and procedural harmonization with other CSS sites
• Account for customer and Regulatory Audits, including coordination and submission of Catalent responses

Requirements

• BS Degree (or regional equivalent) in a Science, Engineering or Pharmaceutical discipline
• 10+ years of experience working in a chemical, pharmaceutical, food or relevant industry with 5+ years experience in QA/RA areas with progressive responsibilities
• Experience in managing people, providing leadership, and implementing developmental plans for personnel
• Direct experience and working knowledge of Validation principles, including validation of processes, equipment, systems, analytical methods, cleaning and transportation
• Working knowledge of US and International cGMP regulations and experience working directly with the local and international regulatory agencies
• Demonstrable record of implementing and maintaining quality systems, laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience

Benefits

• Defined career path and annual performance review and feedback process