Product Manager

Product Manager About SiteCatalent’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 SummaryWe have an opportunity for a Product Manager to join our team and coordinate the overall operations of the Catalent Quality Assurance function for assigned products and customers. This role serves as the central contact point for all customer quality inquiries and ensures that all customer quality needs are met. You will play a key role in making sure that all products released for patients are safe and compliant. This position is essential to maintaining strong client partnerships and supporting the organization’s quality goals.Shift: Monday-Friday 8 AM - 5 PMLocation: Winchester, KY100% OnsiteThe RoleAct as the primary quality liaison for clients and internal customers, becoming the Subject Matter Expert for client products, processes, and requirements.Support both new and commercial products and processes.Assist with internal, client, and regulatory audits.Maintain systems and procedures to monitor quality system health and ensure audit readiness on client manufacturing floors.Perform statistical analyses and provide routine metrics for customers.Represent Quality in Quality Business Update meetings.Maintain and develop client partnerships to ensure alignment and consensus.Coordinate internal QA functions with customers and Catalent departments, including reviewing and closing investigations, handling non-critical customer complaints, trending product data, approving qualification reports, writing and revising Quality Agreements, and reviewing Annual Product Review/Annual Quality Review sections.Maintain client data sets including metrics, trackers, business review material, and updates to leadership teams.Interface with Operations and Customer Service to maintain partnerships for third-party manufacturing and ensure compliance.Coordinate key systems such as Customer Complaints and other quality-related functions for assigned products and clients.Perform other duties as required to support high performance.The CandidateMinimum RequirementsHigh school diploma or GED required.5+ years of experience in quality and/or regulatory in the pharmaceutical industry OR 7+ years in a regulated industry with understanding of lab, manufacturing, regulatory, and compliance.Ability to communicate successfully at all levels of internal and client organizations and regulatory agencies.Proven ability to work independently.Knowledgeable in auditing principles and able to audit/evaluate manufacturing and support functions for audit preparedness.Self-motivated with strong organizational skills.Highly developed documentation skills.Openly shares information, values feedback, and communicates directly.Knowledge of quality, regulatory, and legal standards including USP, EP, JP, GMP, ICH, DEA, and FDA.Proficient in Microsoft Word, Excel, and PowerPoint; preferred experience in Trackwise and JDE.Ability to read, write, and speak clear English.Individual may be required to sit for an extended period of time.Specific vision requirements include reading written documents and frequent use of a computer monitor.Preferred Skills & BackgroundBachelor of Science in a pharmaceutical-related field preferred but not required.Ability to audit the manufacturing environment preferred.Ability to train others effectively preferred.Why You Should Join CatalentPositive and fast-paced working environment focused on continuous improvement and innovation.Competitive Paid Time Off plus 8 paid holidays.Medical, dental, and vision benefits effective day one of employment.Tuition reimbursement to help you finish your degree or earn a new one.Engaging site-based activities such as NCAA Basketball Brackets, Golf Scrambles, and Annual Onsite Pet Adoption Events.Employee Resource Groups promoting diversity and inclusion.Green initiatives and community engagement, including Adopt-a-Highway clean-up.Defined career path with annual performance reviews and growth opportunities.WellHub program to support physical and mental wellness.Exclusive discounts through Perkspot 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 View email address on click.appcast.io. 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.Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to View email address on click.appcast.io for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE.SummaryLocation: Winchester, KYType: Full time