QA Lead, Operations (Cell Therapy) (W)
On-siteThe Woodlands, Texas, United States
EXPIREDThe Woodlands, Texas, United StatesOn-siteFull TimeSenior LevelBachelors DegreeSmall
Full TimeSenior LevelBachelors DegreeSmall
Job Summary
QA Lead, Operations oversees QA for GMP manufacturing of cellular therapies, acts as the main client-contact for assigned projects, and drives QA oversight across batch release, master batch records, deviations, CAPAs, and regulatory readiness. The role involves cross-functional collaboration (Project Management, AD/PD, Supply Chain, Manufacturing, QAQC), risk mitigation, client interactions, on-site audits, and support for regulatory inspections while enabling timely delivery of client projects and new product introductions.
Required Qualifications
- BS in Life Sciences or related field
- minimum 8 years of experience in biopharmaceutical or regulated pharmaceutical industry
- at least 6 years of experience in Quality Assurance
- strong technical and quality background related to biological manufacturing (cell therapy preferred)
- strong familiarity with commercial GMP processes within biologics
- experience transitioning products from clinical to commercial processes and process validation (preferred)
- ability to apply scientific and regulatory principles to solve operational and quality tasks
- self-starter with ability to deliver results in fast-paced environment
- strong knowledge of GMPs, 21 CFR Parts 210, 211 and related regulations (ICH, EU GMPs)
- effective written and oral communication with all levels including regulatory inspectors
- ability to lead cross-functional teams and manage client project activities
- experience with deviations, CAPAs, and root-cause analysis
- training capability for quality processes
- experience with on-site audits and regulatory inspections
- familiarity with electronic systems and reporting (Smartsheet, Excel)
- ability to learn new manufacturing processes quickly
- ability to work independently and in a team
- ability to stay current with regulatory changes and guidance bodies
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