Quality Operations Manager

Catalent Pharma Solutions • Saint Petersburg, FL • 4h ago

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.

Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

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.

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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any @type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .

Similar Jobs

Acceleration Center - AWM Operations Management Consultant - Senior Associate

PwC • Tampa, FL • 7h ago

Management & Administrative

Specialty/Competency: Operations Industry/Sector: Asset and Wealth Management Time Type: Full time Travel Requirements: Up to 40% At PwC, our people in operations consulting specialise in providing consulting services on...

7h ago

Go to Apply

Acceleration Center - AWM Operations Management Consultant - Manager

PwC • Tampa, FL • 7h ago

Management & Administrative

Specialty/Competency: Operations Industry/Sector: Not Applicable Time Type: Full time Travel Requirements: Up to 40% At PwC, our people in operations consulting specialise in providing consulting services on optimising o...

7h ago

Go to Apply

Manufacturing Manager - Production Supervision

GE Vernova • Clearwater, FL • 11h ago

Management & Administrative

Job Description Summary Perform the daily operations of plants to ensure reliability and consistency on the production line. Includes Service Shops. Impacts departmental operations and responsible for planning/execution....

11h ago

Go to Apply

Reservation Manager-1

U-Haul • Palm Harbor, FL • 14h ago

Management & Administrative

Location: 30750 US Hwy 19 N, Palm Harbor, Florida 34684 United States of America U-Haul is looking for someone who enjoys being part of a team, provides outstanding customer service, is results-oriented and wants to work...

14h ago

Go to Apply

Deputy Program Manager - TS/SCI with Poly

General Dynamics Information Technology • Tampa, FL • 16h ago

Management & Administrative

Req ID: RQ219826 Type of Requisition: Regular Clearance Level Must Be Able to Obtain: Top Secret SCI + Polygraph Public Trust/Other Required: None Job Family: Program Delivery and Execution Skills: Enterprise Operations,...

16h ago

Go to Apply

Engineering Manager - TS/SCI with Poly

General Dynamics Information Technology • Tampa, FL • 16h ago

Management & Administrative

Req ID: RQ219828 Type of Requisition: Regular Clearance Level Must Be Able to Obtain: Top Secret SCI + Polygraph Public Trust/Other Required: None Job Family: Professional Engineering Skills: Engineering Leadership,Enter...

16h ago

Go to Apply

Operations Manager - TS/SCI with Poly

General Dynamics Information Technology • Tampa, FL • 17h ago

Management & Administrative

Req ID: RQ219831 Type of Requisition: Regular Clearance Level Must Be Able to Obtain: Top Secret SCI + Polygraph Public Trust/Other Required: None Job Family: Administration Skills: Crisis Management,Enterprise IT,Enterp...

17h ago

Go to Apply

Tech Refresh Manager - TS/SCI with Poly

General Dynamics Information Technology • Tampa, FL • 17h ago

Management & Administrative

Req ID: RQ219833 Type of Requisition: Regular Clearance Level Must Be Able to Obtain: Top Secret SCI + Polygraph Public Trust/Other Required: None Job Family: Program Delivery and Execution Skills: Hardware Deployments,I...

17h ago

Go to Apply

Customer Service Associate

Walgreens • Lithia, FL • 17h ago

Management & Administrative

Job Description: Models and delivers a distinctive and delightful customer experience. Registers sales on assigned cash register, provides customers with courteous, fair, friendly, and efficient checkout service. Custome...

17h ago

Go to Apply

Customer Service Associate

Walgreens • Brandon, FL • 17h ago

Management & Administrative

17h ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)