Apply: Senior Manager/Associate Director – QMS & GCP Quality Assurance

Reference: BH-24464-1

A global life sciences organisation is seeking a QMS & GCP 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
Minimum of 8+ 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

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Apply: Senior Manager/Associate Director – QMS & GCP Quality Assurance

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