Quality Program Manager

Catalent•Philadelphia, PA

30d•Onsite

About The Position

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.

Requirements

Bachelor’s degree is required, life sciences or scientific degree is preferred
Five years of relevant experience working in a pharmaceutical industry or life science industry is required
Must possess regulatory and/or client audit experience
Must have the ability to present Quality/ Compliance information both internally at Catalent and externally to clients
Knowledge of cGMP’s is required

Responsibilities

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

Benefits

Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 hours of PTO + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Community engagement and green initiatives
Generous 401K match
Medical, dental and vision benefits
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