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Location
Singapore
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-24464
Contact
Ann Marie Christopher
Posted
大约 17 小时 前
A leadership opportunity for an experienced Quality professional to shape and govern global GxP standards from a Singapore base.

A global life sciences organisation is seeking a QMS & GxP Quality leader to provide technical and strategic oversight of GCP, GLP and GVP compliance across regional and global operations.

Key Responsibilities:
  • Provide global governance and technical oversight of GCP, GLP and GVP SOPs, ensuring alignment with ICH guidelines and regulatory expectations
  • Act as the QA lead for global and regional regulatory inspections and audits, including inspection readiness, conduct, response strategy and CAPA follow-up
  • Strengthen the Quality Management System (QMS) through evaluation of quality trends, metrics and audit outcomes
  • Partner closely with Clinical Development, Medical Affairs, Pharmacovigilance and Regulatory Affairs to embed evolving regulatory requirements into operational processes
  • Lead inspection readiness programmes and GxP capability-building initiatives across functions and regions
  • Serve as a technical advisor and escalation point for senior stakeholders within a matrixed, international environment

To be shortlisted for this role, you will have:
  • A degree in Life Sciences, Pharmacy or a related discipline
  • 10+ years’ experience in GxP / PV Quality Assurance or Clinical Quality within pharma or biotech
  • Hands-on experience supporting major health authority inspections (e.g. FDA, EMA, PMDA, NMPA)
  • Strong technical knowledge of global GxP regulations and ICH requirements
  • Proven ability to influence and advise senior stakeholders in a matrix environment
 

Qualified candidates who meet the above requirements are encouraged to apply or reach out for a confidential discussion.


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