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Catalent · 2 days ago

Quality Program Manager

Philadelphia, PA

Full-time

Onsite

Mid, Senior Level

5+ years exp

Catalent is a global leader in drug development and delivery, with a facility in the Philadelphia area that specializes in Clinical Supply Packaging. The Quality Program Manager will serve as the quality liaison between the Philadelphia Quality Assurance team and assigned clients, managing audits and ensuring compliance with quality standards.

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

Regulatory audit experienceCGMP knowledgeLife sciences degreePharmaceutical industry experienceClient relationship managementOrganizational skillsPresentation skills

Required

Bachelor's degree is required

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

Preferred

life sciences or scientific degree

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!

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.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees