Quality Manager – South Africa
Core
Lead quality and compliance activities for clinical trial supply operations including packaging, labeling, distribution, returns, and destruction.
Role type
Site Quality Manager
Builds
Clinical trial supply chain operations
Domain
Pharmaceutical / Clinical Research
Deliverable
client delivery
Required skills
Pharmaceutical quality experience, people leadership, quality management systems (cGMP, GDP), deviation/CAPA/complaint/investigation/audit management, training delivery, validation oversight, continuous improvement
Preferred skills
Lead Auditor certification (ISO 13485/9001), regulated quality standards experience (ISO 9001, ISO 13485, FDA QSR), quality management software (TrackWise), Lean/Six Sigma, project management
Technologies
TrackWise
Responsibilities
Lead and develop a Quality team; Ensure compliance with cGMP and GDP; Act as Management Representative for quality and safety systems; Manage deviations, complaints, investigations, and CAPA; Maintain self-inspection program; Support audits; Provide quality guidance; Oversee facility and equipment qualification/validation; Deliver QA/GMP training; Drive continuous improvement using quality data; Partner with leadership to strengthen quality culture
Seniority
Manager, hands-on IC with team leadership
