Product Manager: Annual Quality Reviews

Catalent Pharma Solutions; Winchester (KY); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Competitive PTO

Medical, dental, and vision benefits (

Tuition Reimbursement

WellHub program

Discounts via Perkspot

Job summary

Catalent Winchester, KY seeks a Product Manager for Annual Product Reviews to manage the program, ensure quality, and support regulatory compliance. The role collaborates with Validation, Technical Writing, QA/QC, and Customer Service to ensure alignment and audit readiness.

100% onsite at Winchester, with responsibilities across client data, audits, and quality systems. The candidate will develop and maintain client partnerships, oversee CAPA and trend analyses, and support audits and

Qualifications

• Bachelor degree or equivalent hands‑on experience in a pharmaceutical field.
• Five years of quality/regulatory experience in pharma, or seven years in a regulated industry with knowledge of lab, manufacturing, regulatory and compliance.
• Ability to communicate effectively with internal teams and regulators.
• Knowledge of USP, GMP, ICH, DEA, and FDA standards.
• Proficiency in MS Word, Excel, and PowerPoint.

Responsibilities

• Author Annual Product Reviews to verify process consistency, assess trends, and determine need for changes in specs, production, or control procedures.
• Serve as the primary SME for Annual Product Reviews for clients and internal customers.
• Collect processing data from Batch Records and Certificates of Analysis and maintain client data sets.
• Support internal, client, and regulatory audits.
• Monitor the quality system health and ensure audit readiness.
• Perform statistical analyses and infer process performance for each Annual Product Review.

Skills

Communication at all levels

MS Office

Education

Bachelor of Science in pharmaceutical field or equivalent

Tools

Minitab

PowerBI

Trackwise

JD Edwards

Job description

Catalent Winchester, KY seeks a Product Manager for Annual Product Reviews to manage the program, ensure quality, and support regulatory compliance. The role collaborates with Validation, Technical Writing, QA/QC, and Customer Service to ensure alignment and audit readiness.

100% onsite at Winchester, with responsibilities across client data, audits, and quality systems. The candidate will develop and maintain client partnerships, oversee CAPA and trend analyses, and support audits and