Sr. Project Manager, Quality Assurance (QA)
Core
Senior QA Project Manager ensuring GxP compliance, managing batch records, investigations, and change controls for early-phase clinical drug products.
Role type
Senior IC Quality Assurance Project Manager
Builds
GMP-compliant drug formulations and clinical trial products
Domain
Biopharmaceutical manufacturing / CDMO
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, GxP oversight, batch record review, deviation management, CAPA management, supplier qualification, audit support, change control, risk management, regulatory inspection experience
Preferred skills
Leadership, mentoring, process improvement, cross-functional collaboration, strategic planning
Technologies
Office software (Word, Excel, Access)
Responsibilities
Maintain and revise QA procedures; Perform QA batch record review and disposition; Evaluate deviations and propose batch rejections; Manage Change Controls, CAPAs, and Deviations; Support internal audits and supplier qualification; Coordinate customer audits; Establish QA tracking and trending; Propose continuous quality initiatives.
Seniority
Senior, hands-on IC with leadership responsibilities
