Quality Coordinator

Key Responsibilities:

• Act as the point of contact for system audits, coordinating with QA, GCSO teams, and SMEs to set up, prepare, and follow through on 4-5 audits annually.
• Manage the Regulatory Intelligence (RIN) requirements for GCSO, reviewing evolving regulations, identifying impacted SMEs, and ensuring SOPs and controlled documents remain compliant.
• Support audit responses by assisting SMEs in addressing findings, CAPAs, and post-audit submissions to facilitate timely closure.
• Collaborate with internal teams to amend or create documents in line with updated regulatory guidance.
• Ensure all regulatory and site-specific requirements are met, staying current with GCP regulations and supporting cross-functional communication.

Required Skills:

• 3-5 years’ experience in clinical quality within pharma or CRO organizations, with deep GCP knowledge.
• Proven e...