GMDP Quality Assurance Manager
Core
Lead and manage day-to-day site quality assurance operations for the distribution and manufacturing (secondary packaging & labelling) of clinical trial supplies.
Role type
Quality Assurance Manager (GMDP)
Builds
Compliant clinical trial supply distribution and manufacturing services for biopharmaceutical sponsors.
Domain
Clinical research supply chain / Pharmaceutical manufacturing and distribution
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GDP regulatory compliance, Quality Management System (QMS) maintenance, root cause analysis, risk assessment, batch record review, audit management, team leadership, stakeholder communication
Preferred skills
None stated
Technologies
Microsoft Outlook, Word, Excel
Responsibilities
Lead and manage day-to-day site quality assurance operations; Maintain and ensure compliance with the site Quality Management System (QMS); Ensure compliance with GMP/GDP regulations and relevant regulatory requirements; Oversee and ensure timely completion of quality records (e.g. deviations, complaints CAPAs and Change Controls); Conduct and oversee risk assessments to support quality and business decisions; Review and approve executed batch records; Host or delegate self-inspections, client audits and/or regulatory inspections; Lead, coach, and develop the QA site operations team
Seniority
Manager, operational leadership
