Development Quality Assurance Manager
About The Position
Development Quality Assurance Manager The Development Quality Assurance Manager is a key quality role supporting pre‑commercial development through clinical release for products within the St. Petersburg site. Join Catalent’s 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 Pre‑Commercial 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 cross‑functional collaboration throughout the product lifecycle.
Requirements
- Bachelor’s 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.
Responsibilities
- Serve as primary quality liaison for internal teams and clients.
- Act as SME for product, process, and analytical requirements.
- Coordinate cross‑functional 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 pre‑commercial programs.
- All other duties as assigned.
Benefits
- competitive pay
- day-one benefits
- career growth
- 152 hours of PTO + 8 paid holidays
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What This Job Offers
Job Type
Full-time
Career Level
Manager
