Supervisor, Quality Assurance

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.

We have an opportunity for a Supervisor, Quality Assurance to join our team at the Winchester, KY site. This role provides leadership and supervision within the Quality Assurance function, ensuring compliance with Quality Systems, Finished Product Batch Release, and Change Control. The position supports regulatory inspections, customer audits, and continuous improvement initiatives. It’s a great opportunity to contribute to a high‑performing team dedicated to maintaining the highest standards of quality and compliance.

Shift: Monday-Friday, 2 PM - 10:30 PM

Location:

Winchester, KY 100% Onsite

• Ensure Quality systems comply with corporate and site procedures as well as industry standards, including Annual Product Reviews, Complaints, Investigations, Corrective and Preventive Actions, and Training.
• Supervise the Quality Assurance Associates.
• Participate in Regulatory (FDA) Inspections and Customer Audits.
• Author and maintain detailed Standard Operating Procedures defining Winchester’s Quality Systems.
• Facilitate Investigations, root cause analysis, Complaints process, and Annual Product Review process.
• Manage and track documentation of Corrective and Preventive Action commitments and related trending processes.
• Recommend process changes based on trends from CAPA, Complaints, and Annual Product Reviews.
• Serve as the Quality department liaison and subject matter expert to other departments, customers, and regulatory representatives.
• Act as subject matter expert in Track Wise, Documentum, and other Quality software platforms.
• Communicate and implement Human Resources policies within the department.
• Maintain documentation related to employee performance and timekeeping, and administer discipline as appropriate in coordination with Human Resources.
• Ensure adherence to quality standards governed by current Good Manufacturing Practices, company Quality Policies, and site Standard Operating Procedures.
• Propose, implement, and enforce quality improvements.
• Perform other duties as required.

Individual may be required to sit for an extended period of time. Specific vision requirements include reading of written documents and frequent use of computer monitor. Sustained sitting at desk or workstation with use of phones, computers, and other office equipment required for the position. Static stance/standing as required. File/folder storage with non‑repetitive light weight lifting, reaching, and forward bending as necessary.

Infrequent overhead lifting less than or equal to 15 lbs with the ability to lift up to 35 lbs and push/pull 40 lbs.

• Bachelor's Degree with 2+ years of related work experience; OR Associate Degree with 3+ years of related work experience; OR High School Diploma/GED with 4+ years of related work experience.
• Batch review and cGMP experience totaling 2+ years.
• Strong analytical and investigative skills.
• Proficient in English verbal and written communication skills to convey and receive ideas and instructions within and outside the organization.
• Proficiency in Microsoft…