Development Quality Assurance Manager
The Development Quality Assurance Manager is a key quality role supporting preācommercial development through clinical release for products within the St. Petersburg site.
Join Catalentās flagship Softgel development and manufacturing facility in North America, located in St. Petersburg, FL, with a capacity of 18 billion capsules per year. This role offers competitive pay, day-one benefits, and career growth in a state-of-the-art, turn-key facility.
Position Summary
This position is 100% on-site at the St. Petersburg site.
The Quality Assurance Product Development department provides leadership and oversight for quality systems supporting PreāCommercial Development, Manufacturing, Testing, Early Phase Clinical Packaging, Stability, and Analytical R&D. This role functions as a primary quality liaison ensuring compliance, alignment, and strong crossāfunctional collaboration throughout the product lifecycle.
The Role
Serve as primary quality liaison for internal teams and clients.
Act as SME for product, process, and analytical requirements.
Coordinate crossāfunctional activities for deviations, investigations, CAPAs, change controls, and audit tasks.
Prepare and present quality metrics and reports.
Provide QA technical recommendations based on trend analysis.
Review and approve protocols, reports, specifications, batch records, test methods, and related technical documents.
Support audits, technical transfers, development meetings, and preācommercial programs.
All other duties as assigned.
The Candidate
Bachelorās degree in a scientific discipline (Chemistry preferred) with five years of pharmaceutical QA or related experience required.
Experience with clinical manufacturing QA, QC, or Analytical R&D required.
Strong knowledge of cGMPs, documentation, and regulatory compliance.
Skilled in reviewing protocols, reports, investigations, and deviations.
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 use of computer monitor.
Individualās primary workstation is in the office area, where the noise level is low.To perform this job successfully, an individual must be able to perform each duty satisfactorily.
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!Ā 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.Ā
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers 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.
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