Job Details
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.
Reg. No. R1104906
BeathChapman Pte Ltd
Licence no. 16S8112
