Product Manager-Annual Product Reviews

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

• 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.

• 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, and PowerPoint.
• Physical requirement: Sustained sitting at desk or workstation with use of phones, computers, and other office equipment as required. Static standing as needed. File and folder storage with light lifting, reaching, and forward bending. Infrequent overhead lifting up to 15 lbs, with potential to lift up to 35 lbs and push/pull 40 lbs.

• Experience with Minitab, PowerBI, Trackwise, and JD Edwards.
• Experience working with third-party contract manufacturing in the pharmaceutical industry.
• Demonstrated ability to influence others outside the incumbent’s department.

• Positive and fast-paced working environment focusing on continual improvement and innovation.
• Competitive Paid Time Off plus 8 paid holidays.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition Reimbursement to support educational growth.
• Engaging site-based activities such as sports events, mentorship programs, and community initiatives.
• Employee Resource Groups promoting Diversity and Inclusion.
• Environmentally friendly initiatives including Adopt-a-Highway Clean-up participation.
• Defined career path with annual performance reviews and growth opportunities.
• WellHub program promoting physical and mental wellness.
• Perkspot offering exclusive discounts from over 900 merchants.