Quality Operations Manager

Quality Operations Manager

The Quality Operations Manager is responsible for leading and supporting Quality Operations activities including CAPA management, batch record review and release processes, proactive compliance initiatives, and continuous improvement efforts.

This position is 100% on-site at the St. Petersburg site, the primary Softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. The role will partner closely with Manufacturing, Technical Services, and Quality Leadership to ensure effective investigation execution, documentation quality, timely corrective and preventive action implementation, and ongoing compliance monitoring.

• Manage complex and high-level proactive compliance initiatives and continuous improvement efforts in collaboration with internal stakeholders.
• Provide leadership support and oversight to Quality teams responsible for CAPA management and batch record review and release activities.
• Lead investigation, review/approver, mentorship/coaching, rapid response, operational excellence analysis, technical writing, preventive action planning, and compliance monitoring systems (e.g., Track Wise) training.
• Ensure site proactive compliance initiative training programs meet regulatory and customer requirements.
• Recommend and drive process improvements based on trend data from CAPAs, complaints, investigations, audits, and quality metrics.
• Perform advanced review of supporting documentation including batch documentation, test results, specifications, training records, SOPs, calibration records, and validation documentation.
• Participate in site quality initiatives and support Management Review and metric reporting activities.
• Other duties as assigned.

• Bachelor’s Degree in Science or related field (Chemistry, Microbiology or Biology) and a minimum of five years related experience in QA pharmaceutical manufacturing.
• Prior experience working with investigation writing, including root cause analysis and report writing; experience with annual product reviews preferred.
• Quality Management experience in a GMP regulated pharmaceutical environment.
• Ability to effectively present information and respond to questions from peers, management, suppliers, and customers.
• Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint, Access).
• Working knowledge of cGMPs and OSHA regulations.
• Certified Quality Engineer is a plus.
• Ability to work effectively under pressure to meet deadlines.
• May be required to sit, stand, walk regularly and occasionally lift up to 15 pounds; no lifting greater than 44.09 pounds without assistance.
• Be accessible to manufacturing floor and office staff and to use required office equipment.
• Specific vision requirements include reading written documents and frequent use of a computer monitor.

• 152 hours of PTO + 8 paid holidays.

Work Hours &

Location:

Monday – Friday, on-site at the St. Petersburg facility.

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 Disabili