Supervisor, Quality Assurance

Regulatory Toolkit; Winchester (KY); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition Reimbursement

Paid time off and holidays

Job summary

Catalent’s Winchester, KY site is seeking a Supervisor, Quality Assurance to lead QA activities, ensure compliance with quality systems, and support regulatory inspections and audits. The role involves supervising QA Associates and maintaining SOPs, CAPA, and change control processes onsite.

The position emphasizes strong document control, investigation skills, and collaboration across departments to sustain high quality standards at a flagship manufacturing site.

Qualifications

• Bachelor's degree with related work experience or equivalent (2+ years for BS, 3+ years for A.A., 4+ years for HS).
• Batch review and cGMP experience totaling 2+ years.
• Strong analytical and investigative skills.
• Proficiency in English communication and MS Office.

Responsibilities

• Ensure Quality systems comply with procedures and industry standards, including reviews, investigations, CAPA, and training.
• Supervise the Quality Assurance Associates.
• Participate in regulatory inspections and customer audits.
• Author and maintain SOPs for Winchester’s Quality Systems.
• Facilitate investigations and root-cause analysis; manage CAPA tracking.

Skills

Leadership

TrackWise

Quality Systems

Investigations

Education

Bachelor's Degree in Life Science

Tools

TrackWise

Documentum

Job description

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 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

The Role

• 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 TrackWise, 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.

The Candidate

Minimum Requirements

• 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 Word, PowerPoint, Excel, and Access.
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent‑sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
• Physical Requirements: 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.

Preferred Skills & Background

• Prior supervisory or management experience (will immediately have 5 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.

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 – support to complete or earn a new degree.
• Site‑based Employee Engagement activities such as NCAA Basketball Brackets, Golf Scrambles, Annual Onsite Pet Adoption Events, and Mentorship Partnerships with Local Schools.
• Employee Resource Groups focusing on Diversity and Inclusion.
• Environmentally friendly community engagement initiatives, including Adopt‑a‑Highway Clean‑up participation.
• Defined career path with annual performance reviews and growth potential within an organization dedicated to improving lives.
• WellHub program promoting physical and mental wellness.
• Perkspot offering exclusive discounts from over 900 merchants across various categories.

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.

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.

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.

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