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.

Position Summary

This position is 100% on-site at the St. Petersburg site.

Monday - Friday hours

St. Petersburg is our primary Softgel development and manufacturing facility in North America with capacity of 18 billion capsules per year.  Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.

This 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.

The Role

• Manage complex and high-level proactive compliance initiatives and continuous improvement efforts in collaboration with internal Catalent stakeholders.

• Provide leadership support and oversight to Quality teams responsible for CAPA management and batch record review and release activities.

• Provide lead investigator, reviewer/approver, mentorship/coaching, rapid response, operational excellence analysis, technical writing, preventive action planning, and compliance monitoring systems (e.g., TrackWise®) 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.

The Candidate

• Bachelor’s Degree in Science or related field required (Chemistry, Microbiology or Biology); with a minimum of five years related experience in QA pharmaceutical manufacturing.

• Prior experience working with investigation writing, including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred).

• Quality Management previous experience in 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/or OSHA regulations required. Certified Quality Engineer is a plus.

• Ability to work effectively under pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift 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 of written documents and frequent use of computer monitor.

Why You Should Work At Catalent

• Spearhead exciting and innovative projects

• Fast-paced, dynamic environment

• High visibility to members at all levels of the organization

• 152 hours of PTO + 8 paid holidays

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.

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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 DisabilityAccommodations@catalent.com. 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.

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