Lead - R&D Quality

Lead Quality - R&D

Role Purpose

Lead the R&D Quality Assurance function and establish a robust quality framework across the product development lifecycle. 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.

Key Responsibilities

• 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, stability, scale-up and technology transfer.
• Embed a strong Quality by Design (QbD) and first-time-right mindset across R&D, driving high standards of scientific documentation, data integrity and development discipline.
• Define appropriate quality standards, controls and risk-based approaches across different stages of the product development lifecycle.
• Act as the primary Quality partner to R&D leadership and provide independent quality oversight and guidance on critical development decisions.
• Development Quality & Documentation
• Provide Quality oversight for the development, review and approval of specifications for raw materials (RM), packaging materials (PM), semi-finished goods (SFG) and finished goods (FG), as well as SOPs, STPs, GTPs and other technical documentation.
• Ensure development activities and documentation comply with applicable GLP, cGMP, data integrity and other relevant regulatory and industry standards.
• Drive right-first-time documentation practices and strengthen controls to minimize errors, deviations and documentation gaps.
• Ensure appropriate management of deviations, change controls, investigations, CAPA and other quality events arising during development.
• Conduct and oversee risk-based audits of R&D laboratories, laboratory notebooks, electronic records, data-management practices and development documentation.
• Product Quality Oversight
• Provide independent Quality oversight of All R&D activity analytical and microbiology development practices, methods, specifications and controls in partnership with Analytical Development (ADL) and Formulation Development (FD) and packaging team PD) teams, and claim susbtanciation.
• Critically evaluate analytical risks and limitations and ensure appropriate mitigation strategies are established during development.
• Partner with cross-functional teams to establish scientifically justified quality evaluation parameters and acceptance criteria for raw materials, intermediates and finished products.
• Oversee the quality governance of stability programs, including protocols, sample management, data review and escalation/investigation of OOS and OOT results.
• Ensure appropriate investigation, root-cause analysis and CAPA for significant quality or analytical failures.
• Technology Transfer & Manufacturing Interface
• Provide Quality leadership for technology transfer from R&D to manufacturing sites, ensuring completeness and robustness of technical and quality documentation.
• Establish appropriate Quality gates and readiness criteria for scale-up, validation and commercial transfer.
• Partner with Site QA, Manufacturing, R&D and other stakeholders to address manufacturing concerns and product/process failures originating from or linked to development.
• Participate in investigations, root-cause analysis and CAPA implementation to ensure sustainable resolution of development and technology-transfer issues.
• Support technology transfers across multiple manufacturing locations and ensure consistent deployment of approved product and process requirements.
• Regulatory & Compliance Partnership
• Partner with global and local Regulatory teams to ensure product, process and analytical compliance throughout development.
• Provide Quality input into technical and regulatory documentation and support responses to regulatory queries related to product development, specifications, analytical methods, stability and manufacturing transfer.
• Ensure relevant technical documentation is complete, accurate and submitted to business hubs/centres and other stakeholders within agreed timelines.
• Maintain awareness of evolving regulatory expectations and industry best practices and translate relevant changes into R&D Quality systems and ways of working.
• Quality Culture, Risk Management & Continuous Improvement
• Build a proactive Quality culture within R&D where Quality is embedded into scientific decision-making rather than applied primarily as a final compliance check.
• Identify systemic quality risks and recurring failure modes across R&D and lead cross-functional initiatives to eliminate root causes.
• Establish meaningful R&D Quality metrics and periodically review trends related to deviations, CAPA, documentation accuracy, stability, OOS/OOT, technology transfer and other critical quality indicators.
• Lead cross-functional resolution of critical quality issues, bringing together R&D, Regulatory, Manufacturing, Site QA and other stakeholders to minimize product, project and business impact.
• Drive simplification and continuous improvement of R&D Quality systems while maintaining appropriate scientific and regulatory rigor.

• Masters in Pharmacy or equivalent
• 15 - 20 years demonstrated experience in R & D/manufacturing/Corporate quality assurance function.
• Prior experience in handling products under Pharma or Personal care with sound knowledge of global practices and regulatory requirements.
• Experience of managing direct reports and collaborations globally with diverse teams
• In-depth understanding of analytical practices

• Agile & pragmatic approach balancing business expectations with quality needs.
• Team orientation, can-do attitude and ability to deliver breakthrough results
• Art of negotiations, creative, follow-through -desired traits
• Ability to set up clear objective and priority-setting
• Knowledge of digital tools/processes/systems
• Proficient in written and oral communication in English