Supervisor, Quality Assurance

Catalent Pharma Solutions•Winchester, KY

12d•Onsite

About The Position

The Supervisor, Quality Assurance provides leadership and supervision within the Quality Assurance function at Catalent’s Winchester, Kentucky site. The role ensures compliance with Quality Systems, finished product batch release, change control, current Good Manufacturing Practices, company Quality Policies, and site procedures. It supports regulatory inspections, customer audits, and continuous improvement initiatives. The supervisor leads Quality Assurance Associates and serves as a Quality department liaison and subject matter expert for other departments, customers, and regulatory representatives. The role oversees quality processes including annual product reviews, complaints, investigations, corrective and preventive actions, training, and associated documentation and trending. It also contributes to department personnel matters, including communicating Human Resources policies and maintaining employee performance and timekeeping documentation. This is a 100% onsite position in Winchester, Kentucky, working Monday through Friday from 2:00 PM to 10:30 PM.

Requirements

Bachelor's degree and at least 2 years of related work experience; or an Associate degree and at least 3 years of related work experience; or a High School Diploma/GED and at least 4 years of related work experience.
At least 2 years of combined batch review and cGMP experience.
Strong analytical and investigative skills.
Proficient English verbal and written communication skills to convey and receive ideas and instructions within and outside the organization.
Proficiency in Microsoft Word, PowerPoint, Excel, and Access.
Physical ability to sit for extended periods; read written documents; frequently use a computer monitor; work at a desk or workstation with phones, computers, and other office equipment; stand as required; and perform light lifting, reaching, and forward bending for file/folder storage. Infrequent overhead lifting of up to 15 pounds, lifting up to 35 pounds, and pushing or pulling up to 40 pounds may be required.

Nice To Haves

Prior supervisory or management experience; the role will immediately have five direct reports.
TrackWise Quality Management System experience.
Strong technical writing skills for investigations, deviations, Corrective and Preventive Actions, and root cause analysis.
Bachelor's degree in Life Science.
Demonstrable leadership experience at Catalent, including participation in programs such as NGGL, GOLD, LEAD Now, GM Excellence, or GROW, may be considered in place of external experience.

Responsibilities

Ensure Quality Systems comply with corporate and site procedures and industry standards, including those for Annual Product Reviews, Complaints, Investigations, Corrective and Preventive Actions, and Training.
Supervise Quality Assurance Associates.
Participate in FDA regulatory inspections and customer audits.
Author and maintain detailed Standard Operating Procedures defining Winchester’s Quality Systems.
Facilitate investigations, root cause analysis, the complaints process, and the Annual Product Review process.
Manage and track documentation for 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 a subject matter expert in TrackWise, Documentum, and other Quality software platforms.
Communicate and implement Human Resources policies within the department.
Maintain employee performance and timekeeping documentation, 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.