Overview

Quality Assurance Lead Jobs in North Macedonia at Planet Pharma

Title: Quality Assurance Lead

Company: Planet Pharma

Location: North Macedonia

An exciting opportunity has arisen for a Clinical QA Lead (GCP Auditor) to join a global, quality-driven organisation on an 18-month maternity cover. This is a fully remote position with minimal travel, offering a highly hands-on role focused on GCP audits and clinical quality oversight.

Key Responsibilities:

  • Lead and support GCP audits and regulatory inspections (preparation, conduct, reporting, CAPAs)
  • Act as an SME for clinical quality topics across operational teams
  • Manage and review CAPAs, deviations, and quality events within the eQMS
  • Support inspection readiness and client audit activities
  • Collaborate cross-functionally with clinical and operational teams
  • Contribute to QMS processes, including change control and document management
  • Identify trends and drive continuous quality improvement initiatives

Requirements:

  • Minimum 5 years’ experience in Quality Assurance within pharma, biotech, or CRO
  • At least 2 years’ experience leading GCP audits (essential)
  • Strong knowledge of GxP, particularly GCP
  • Hands-on experience with eQMS (CAPAs, deviations, change management)
  • Experience supporting regulatory inspections and client audits
  • Excellent communication and stakeholder management skills
  • CRO experience is highly desirable

What’s on Offer:

  • Fully remote working
  • Minimal travel (~5%)
  • Highly hands-on audit-focused role
  • Opportunity to join a collaborative, global QA team
  • Fast-moving interview process

If you’re a GCP auditor looking for a role where you can make an immediate impact and stay close to the operational side of quality, this could be a great opportunity to explore.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

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