ERGOMED

Quality Assurance and Compliance Manager

ERGOMED

full-time

Posted on:

Location Type: Remote

Location: Qatar

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About the role

  • Supports the (Associate) Director, Quality Assurance by leading all aspects of the design, implementation and management of internal and vendor audits and corresponding Quality Risk Management activities.
  • Fosters a culture of quality within the PrimeVigilance organisation and acts as an ambassador for the PV QA department.
  • Plays an active role in the preparation, maintenance, and execution of the internal Tactical Audit Program and will lead and/or co-audit, internally.
  • Represents PV QA in their interaction and exposure to our clients within PV Operations.
  • Develops and maintains a comprehensive Audit Universe.
  • Develops and maintains the internal Quality Risk Assessment methodology.
  • Leads Quality Assurance activities in relation to procurement and vendor oversight.
  • Develops, maintains, and manages mechanisms that assure ongoing monitoring and compliance with all applicable laws and regulations including but not limited to EU GVP, USFDA CFRs, JMPA and ICH-E6.
  • Coordinates and contributes to internal system and/or vendor audits initiated by PrimeVigilance, including effective management of pre-audit and post-audit activities.
  • Supports the Audit CAPA team in the effective management of CAPAs arising from vendor audits.
  • Hosts and supports audits and inspections of PrimeVigilance performed by clients/third parties and regulatory authorities as agreed with (Associate) Director, Quality Assurance and/or VP of Quality.
  • Conducts or coordinates audit documentation peer review and quality control activities.
  • Monitors compliance within the organisation to ensure early identification and resolution of quality issues.
  • Assesses audit findings and recommendations, and identifies process improvement initiatives via trending data as provided by other Quality teams.
  • Fosters a culture of quality within the organisation as led by members of the Quality Leadership Team.

Requirements

  • University degree in biomedical sciences, natural sciences or health sciences, or a Bachelor’s or Master’s degree in a scientific discipline or an equivalent advanced degree with experience, or equivalent industry experience.
  • Previous experience in a regulated industry in a quality setting, preferably in pharmaceuticals or healthcare.
  • Thorough understanding of the principles of Quality Assurance
  • Experience of participating in audits and inspections
  • Excellent communication and facilitation skills within a global organization
  • Proactive and self-motivated
Benefits
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Applicant Tracking System Keywords

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Hard Skills & Tools
Quality Risk ManagementAudit documentationQuality Assurance principlesCompliance monitoringCAPA managementInternal auditsVendor auditsQuality control activitiesProcess improvement initiativesRegulatory compliance
Soft Skills
Communication skillsFacilitation skillsProactiveSelf-motivatedLeadershipOrganizational skillsInterpersonal skillsTeam collaborationProblem-solvingCultural awareness