Quality Program Manager

Quality Program Manager

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

This position is responsible for being the quality liaison between Philadelphia Quality Assurance and the client. Specific clients will be assigned to each Quality Program Manager with whom they will support and develop a quality relationship. The Quality Program Manager must be flexible and have well-developed organizational skills and the ability to interact with all levels within the organization.

This is a full-time on-site salaried position, Monday - Friday 8 : 00am - 4 : 30pm.

Catalent is committed to a patient first culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role :

• Work closely with Catalent Philadelphia site to obtain necessary quality information for clients to support their projects and requests
• Plan, schedule, manage, and host customer, corporate, and internal audits. Support regulatory inspections as required
• Track audit reporting, drive completion of Catalent response to audit findings, and closure of audit actions
• Attend project kick-off meetings to assist various departments with understanding the project from a Quality perspective
• Attend client preparation calls and visits to ensure that the client receives any appropriate documentation requested and get questions answered
• Act as the primary contact person for client-specific quality questions and be the quality liaison between client and Catalent staff; Act as the primary contact with clients if there are quality questions on documentation, process questions, issues, etc
• Be knowledgeable about customer-specific requirements. Ensure they are built into the process and communicated to relevant Catalent staff
• Review deviation and complaint reports and address trends. Prepare communications regarding the results where appropriate and requested
• Other duties as assigned

The Candidate :

Why you should join Catalent :

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Personal initiative. Dynamic pace. Meaningful work.