Product Manager-Annual Product Reviews

Catalent Pharma Solutions; Winchester (KY); Sur place; USD 85 000 - 115 000; Plein temps

Avantages offerts par ce poste

Competitive PTO

Medical, dental, and vision benefits (

Tuition Reimbursement

WellHub program

Discounts via Perkspot

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Communication at all levels

MS Office

Formation

Bachelor of Science in pharmaceutical field or equivalent

Outils

Minitab

PowerBI

Trackwise

JD Edwards

Description du poste

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.

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, 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.

Preferred Skills & Background

• 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.

Why You Should Join Catalent

• 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.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.