Head of quality

Job Title: Head – Quality (India Operations: R&D & Manufacturing) Location: Panoli, Gujarat, India Position Summary The Head – Quality will provide end-to-end leadership of the Quality function across Discovery & Process Research R&D centres and the Manufacturing Plants. The role is accountable for ensuring that all R&D and manufacturing operations meet global regulatory requirements and that a culture of Quality and continuous improvement is embedded throughout the organisation. Key Responsibilities Strategic & Leadership Define and implement the Quality strategy for India Operations covering R& D (Discovery Chemistry, Process R& D) and the Manufacturing Plant . Act as the primary Quality representative in the India Leadership Team and partner with Global QA to align corporate and site quality standards. Drive a culture of quality ownership, data integrity and right-first-time execution across R& D and manufacturing. Quality Systems & Regulatory Compliance Establish and maintain a robust Quality Management System (QMS) to comply with ICH, USFDA, EMA, MHRA, OECD-GLP and c GMP requirements. Lead and oversee GMP/GLP compliance across laboratories and manufacturing operations. Plan and manage internal audits, customer audits and regulatory inspections , ensuring timely closure of observations and effective CAPA management. Oversee change control, deviation management, OOS/OOT investigations, and document control for both R& D and manufacturing units. R& D & Manufacturing Interface Provide Quality oversight for tech transfer activities from R& D to the manufacturing plant, ensuring Qb D principles and regulatory expectations are met. Partner with Process R& D and Manufacturing teams to assure scale-up and commercial production quality . Plant Quality Assurance Lead all Plant QA functions including in-process quality checks, batch release, quality control liaison, validation and qualification activities. Ensure site readiness for all regulatory and customer inspections and maintain continuous state of audit readiness. People & Culture Build, mentor and develop a multi-site QA team , creating strong succession pipelines and enhancing technical capabilities. Champion training programs on global quality standards, regulatory updates and best practices. Risk Management & Continuous Improvement Identify and proactively manage quality risks across R& D and manufacturing. Introduce digital tools, analytics and automation to improve compliance, efficiency and decision making. Qualifications & Experience Master’s degree in Pharmaceutical Sciences / Chemistry / Life Sciences ; Ph. D. preferred. 20+ years of progressive QA experience in pharmaceutical / biotech / CDMO organisations , with at least 5–7 years in a senior leadership role . Strong track record in R& D QA (Discovery & Process Research) and Manufacturing QA within a regulated environment. In-depth understanding of global regulatory frameworks (USFDA, EMA, MHRA, ICH, OECD-GLP, c GMP). Proven success in leading multi-location QA teams , managing customer and regulatory inspections, and implementing robust QMS. Key Competencies Strategic Leadership & Influence – ability to shape quality vision across R& D and manufacturing. Technical Expertise – mastery of QMS, regulatory compliance, and technology transfer quality controls. Change & Risk Management – driving cultural change and proactive risk mitigation. Collaboration & Communication – effective engagement with R& D, Manufacturing, Regulatory and Corporate leadership. Decision Making & Business Acumen – balancing regulatory rigor with operational realities. Reporting Line Reports to: Global Head of Quality