Product Manager-Annual Product Reviews

About Site Catalent’s Winchester, KY site is the company’s flagship U.S. manufacturing location for large‑scale oral solid dose forms, operating from a 180,000‑square‑foot facility with fully integrated development and analytical services. The site specializes in complex and controlled‑release oral dose technologies, supporting product development, technology transfer, and commercial manufacturing across pharmaceutical and consumer health programs. Winchester has a long commercial manufacturing track record, having launched 100+ products and producing billions of tablets and capsules annually, making it a critical site within Catalent’s oral dose network.

Position Summary We have an opportunity for a Product Manager-Annual Product Reviews to join our team. This role is responsible for managing the Annual Product Review program at Catalent‑Winchester, ensuring the highest quality standards and regulatory compliance. The position supports departmental strategic goals and collaborates across teams to maintain effective quality systems. The successful candidate will play a key role in maintaining client partnerships and supporting audits and inspections.

Shift: Mon‑Fri, standard business hours

Location:

Winchester, KY 100% Onsite

The Role 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. Interface with internal teams such as Validation, Technical Writers, Quality Assurance, Quality Control, Product Development, and Customer Service to ensure quality and compliance.

Coordinate key systems including Customer Complaints and functions impacting the Quality area related to assigned products and clients. Support the Quality Compliance and Regulatory department during FDA and other agency inspections as well as customer and internal audits. Ensure coordination and compliance with Standard Operating Procedures and current Good Manufacturing Practices through observation and implementation of Annual Product Review findings.

Provide additional Quality Assurance support and functions as specified by the Supervisor. Maintain effectiveness of the Quality System components relevant to this position. Perform other duties as required.

The Candidate Minimum Requirements Bachelor of Science in a pharmaceutical applicable field or equivalent hands‑on experience; examples include Science, Biology, Chemistry, or Engineering. 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,…