QA Product Manager – Pharmaceutical Quality & Compliance

Catalent

Winchester (KY)

On-site

USD 90,000 - 120,000

Full time

10 days ago
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Benefits offered by this job

Medical, dental, and vision benefits
Tuition reimbursement
Paid time off
Employee discounts

Job summary

Catalent is seeking a Product Manager to coordinate the QA function for assigned products and clients at the Winchester, KY site. This role ensures products released for patients are safe and compliant, serving as the main contact for customer quality inquiries and supporting audits.

Shifts are Monday–Friday, 8 AM to 5 PM, onsite in Winchester, KY. The role emphasizes collaboration with Operations and Customer Service to maintain compliance across third‑party manufacturing and client

Qualifications

  • Minimum 5+ years in quality/regulatory in pharma OR 7+ years in a regulated industry with lab/manufacturing/regulatory exposure.
  • Ability to communicate at all levels of internal and client organizations and with regulatory agencies.
  • Proven ability to work independently and audit manufacturing/support functions for readiness.

Responsibilities

  • Act as the primary quality liaison for clients and internal customers.
  • Support new and commercial products and processes.
  • Assist with internal, client, and regulatory audits.

Skills

Quality assurance
Regulatory knowledge
Auditing
Client communication
Microsoft Excel
Trackwise
JDE
English fluency

Education

High school diploma or GED
Bachelor's degree in pharmaceutical field (preferred)

Tools

Trackwise
JDE
Microsoft Word
Microsoft PowerPoint

Job description

Catalent is seeking a Product Manager to coordinate the QA function for assigned products and clients at the Winchester, KY site. This role ensures products released for patients are safe and compliant, serving as the main contact for customer quality inquiries and supporting audits.

Shifts are Monday–Friday, 8 AM to 5 PM, onsite in Winchester, KY. The role emphasizes collaboration with Operations and Customer Service to maintain compliance across third‑party manufacturing and client

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