Director, Quality
On-site · Philadelphia, Pennsylvania, United States
Job Summary
Director of Quality responsible for providing leadership and Quality Management support within Clinical Specialty Services divisions, with responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control, and Customer relations. Oversees staff development, performance management, and hiring decisions; promotes and maintains quality initiatives to ensure compliance with global regulations and client requirements. Leads data integrity and Computer System Validation activities across GXP operations; supports client audits and regulatory inspections; drives quality improvement through investigations, root-cause analysis, and CAPAs. Requires a BS/BA in a scientific discipline or equivalent experience and 10+ years of pharmaceutical Quality Assurance experience, with strong knowledge of cGMPs, regulatory expectations, and effective leadership and communication skills.
Required Qualifications
- BS or BA in Chemistry, Biological Sciences, or other related scientific discipline or equivalent experience
- 10 + years of Scientific or Pharmaceutical Quality Assurance experience, preferably clinical supply services, in addition to commercial packaging
- Clear understanding of cGMPs including clinical trials
- Communicates clearly with internal and external clients, both verbal and written
- Cooperates with co-workers; is a team player
- Willingness to contribute to team activities
- Demonstrates flexibility in organizing work and priorities
- Good organizational skills relating to management of associates’ daily activities
- Good problem-solving skills and decision-making skills to identify and solve work related issues
- Good change management skills and strategic thinking
- Demonstrable leadership experience at Catalent (or equivalent)
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.