Product Manager

Position Summary

We 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 PM
Location: Winchester, KY
100% Onsite

The Role

• Act 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 Candidate

Minimum Requirements

• High 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 & Background

• Bachelor 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 Catalent

• Positive 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.