This is a high-impact, business-facing role with a leading pharmaceutical organisation, where you will act as a trusted QA partner to Clinical and Medical Affairs teams, embedding Quality by Design (QbD) and strengthening a proactive quality culture across the region.
A strategic, high-visibility regional leadership role where you will have direct influence on quality culture and business outcomes and the opportunity to work with global stakeholders and regulators and be a part of a forward-thinking, quality-driven organization.
The Associate Director, Clinical and Medical QA will:
- Lead risk-based quality oversight across clinical development and medical activities
- Drive inspection readiness & regulatory interactions (FDA, PMDA, MHRA, etc.)
- Partner cross-functionally to embed QbD principles across the product lifecycle
- Oversee quality events, investigations, root cause analysis (RCA) & Corrective And Preventive Actions(CAPAs)
- Influence and enhance QMS frameworks and continuous improvement initiatives
- Act as a regional QA leader, shaping strategy and execution across APAC
To be shortlisted for the role, you will come with
- 15+ years in GxP Quality within Pharma / Biotech / MedTech
- Strong experience in Development QA / Clinical QA / Medical Affairs QA
- Proven track record with regulatory inspections & health authority interactions
- Deep understanding of drug development lifecycle (R&D, PV, MA)
- Experience across global/regional environments
- Oncology exposure is a plus
If the role sounds like you, apply now or reach out directly for a confidential conversation.
AMC
Reg. No. R1110770
BeathChapman Pte Ltd
Licence no. 16S8112
