Director, Quality Position Summary: Catalent's 206,878-square-foot Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services. The site provides manual to fully automated packaging solutions, including temperature-controlled options for sensitive products. Come and be part of a team that delivers industry-leading quality and innovation.
The Quality function is to build, monitor, and sustain a robust and effective quality system that delivers reliable, high-quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality system establish the requirements for and measure how Catalent complies with all applicable regulations and guidance world-wide, including but not limited to, good manufacturing practice/quality system requirements of the Food and Drug Administration, state boards of pharmacy, European, South American, Japanese, and Australian agencies and other international and/or local health authorities.
The Director of Quality is responsible for providing leadership and Quality Management support within each of the Clinical Specialty Services divisions. This individual will have responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control, and Customer relations.
The Role: - Provides direction and guidance to the Quality Disposition, Materials Sampling Quality Assurance, Regulatory and Compliance Quality Assurance, and Validation Quality Assurance.
- Management responsibilities include professional development, performance appraisals, and employee counselling for direct reports. Assigns work and reviews workload for all direct reports. Supervises staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
- Recommends courses of action on all management/human resources' matters, including salary administration, transfers, hiring, terminations, and position description preparation.
- Promotes, implements, and maintains quality initiatives of processes and programs to assess compliance with regulations, Global and Site SOPs, and client requirements.
- Provides to the Operational CDS and Quality organization consultation, and interpretation of regulations/guidelines related to GXPs focused mainly on good clinical trials, as applicable.
- Writes and approves Quality unit SOPs and Forms, as needed. Approves Operational CDS SOPs and Forms. Supports harmonization of worldwide Quality operating procedures as needed.
- Provides leadership for Data Integrity and Computer System Validation documentation review and approval for instruments, equipment, and systems used in GXP Operations throughout the system life cycle.
- Assist with Client Audit and Regulatory Agency inspections.
- Provides direction in identification and implementation of quality improvement programs.
- Provides leadership for the investigation, root cause analysis, and CAPAs association with Deviations, Non-conformances, Complaints, Client Audits, and Internal Audit Reports.
The Candidate:- BS or BA in Chemistry, Biological Sciences, or other related scientific discipline or equivalent experience.
- 10 + years of Scientific or Pharmaceutical Quality Assurance, preferring 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 (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.
