Catalent · 5 hours ago
Quality Program Manager
Philadelphia, PA
Full-time
Onsite
Mid, Senior Level
5+ years expCatalent, Inc. is a leading global contract development and manufacturing organization dedicated to improving health and well-being. The Quality Program Manager serves as the key liaison between the Philadelphia Quality Assurance team and clients, ensuring quality needs are met and facilitating audits and project support.
BiotechnologyHealth CareManufacturingPharmaceutical
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
Qualification
Required
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
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
Tuition Reimbursement - Let us help you finish your degree or start a new degree!
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Company
Catalent
Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
unknown2021-01-06Acquired
Leadership Team
Alessandro Maselli
President & Chief Executive Officer
Charles Lickfold
Senior Vice President, Chief Information Officer
Recent News
2026-01-22
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