Quality Program Manager

Catalent•Philadelphia, PA

10d•Onsite

About The Position

Quality Program Manager Position Summary: Work Schedule: Monday - Friday, 8:00am - 4:30pm 100% on-site 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. 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.

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
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 hours of PTO + 8 paid holidays
Generous 401K match
Medical, dental and vision benefits
Tuition Reimbursement - Let us help you finish your degree or start a new degree!
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.