Lead - R&D Quality

About the role

The role will ensure that products, processes, analytical methods and technical documentation are developed in accordance with Quality by Design principles, applicable regulatory requirements and internal quality standards, while enabling speed, scientific rigor and successful technology transfer from R&D to manufacturing.

What you'll do

• R&D Quality Leadership & Governance
• Lead and manage the R&D Quality Assurance function, including capability development and performance management of the R&D-QA team
• Establish and continuously strengthen the R&D Quality Management System (QMS), ensuring appropriate governance across formulation development, analytical development
• Embed a strong Quality by Design (QbD) and first-time-right mindset across R&D, driving high standards of scientific documentation
• Define appropriate quality standards, controls and risk-based approaches across different stages of the product development lifecycle

What you need

• 15–20 yrs of experience
• GLP
• GMP
• Microbiology
• Documentation
• Root cause analysis
• Performance management
• Any graduate

Good to have

• ISO 9001
• SOP writing