Onsite QA Product Manager – Annual Reviews & Compliance

Catalent, Inc.; Winchester (KY); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive PTO and 8 holidays

Benefits from day one

Tuition reimbursement

Job summary

Catalent, Inc. in Winchester, KY is seeking a Product Manager-Annual Product Reviews to oversee the annual review program and ensure quality system readiness. This role partners with internal teams and clients to verify trend data and approve specification changes as needed.

The successful candidate will support audits, regulatory inspections, and maintain client data sets while ensuring regulatory compliance and document control. This is a Mon-Fri onsite position supporting quality initiatives.

Qualifications

• Bachelor of Science in a pharmaceutical applicable field or equivalent hands‑on experience.
• Five years of experience in quality and/or regulatory in the pharmaceutical industry, or seven years in a regulated industry with understanding of laboratory, manufacturing, regulatory, and compliance.
• Ability to communicate effectively at all levels of internal and client organizations and regulatory agencies.
• Knowledge of quality, regulatory, and legal standards including United States Pharmacopeia, Good Manufacturing Practices, International Council for Harmonisation, Drug Enforcement Administration, and Food and Drug Administration.
• Proficiency in Microsoft Word, Excel, and PowerPoint.

Responsibilities

• Author Annual Product Reviews to verify process consistency, assess trends, and determine the need for changes in specifications, production, manufacturing, or control procedures.
• Serve as the primary subject matter expert for Annual Product Reviews for clients and internal customers.
• Collect processing data from Executed Batch Records and Certificates of Analysis and maintain client data sets.
• Support internal, client, and regulatory audits.
• Maintain systems and procedures to monitor the health of the quality system and ensure audit readiness.
• Perform statistical analyses and infer process performance for each Annual Product Review as scheduled.
• Develop and nurture client partnerships to ensure alignment and consensus regarding Annual Product Reviews.
• Coordinate functions of the internal Quality Assurance organization with customers and relevant Catalent departments.

Skills

Communication

Client/vendor liaison

Education

Bachelor of Science in pharmaceutical field

Tools

Minitab

PowerBI

Trackwise

JD Edwards

Job description

Catalent, Inc. in Winchester, KY is seeking a Product Manager-Annual Product Reviews to oversee the annual review program and ensure quality system readiness. This role partners with internal teams and clients to verify trend data and approve specification changes as needed.

The successful candidate will support audits, regulatory inspections, and maintain client data sets while ensuring regulatory compliance and document control. This is a Mon-Fri onsite position supporting quality initiatives.