10+ years gcp experience in pharmaceutical industry
Degree level education or equivalent experience
Experience managing regulatory health authority gxp inspections
The role serves as the independent second line assurance function for R&D, focusing on auditing, quality management, and risk assessment
Job Summary
The role serves as the independent second line assurance function for R&D, focusing on auditing, quality management, and risk assessment.
The job holder is responsible for strategic development of a GXP risk-based quality assurance program and conducting complex audits across the APAC region.
Candidates must provide proactive end-to-end GXP inspection support and lead directed audits while maintaining high ethical standards.
Matching Summary
The role serves as the independent second line assurance function for R&D, focusing on auditing, quality management, and risk assessment.
Skills & Requirements
Must-have
10+ years GCP experience in pharmaceutical industry
Degree level education or equivalent experience
Experience managing regulatory health authority GxP inspections
Audit expertise in investigator site and supplier audits
Fluent written and spoken English skills
Nice-to-have
Project management experience
Six sigma lean process improvement tool knowledge
Key account management experience
Strong collaborative and influencing interpersonal skills
Ability to maintain professional stakeholder networks
Key Requirements
10+ years' experience of GCP in Pharmaceutical industry
Degree level education or equivalent experience
Experience in managing regulatory health authority GxP Inspections