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Head of Quality
PI Health Sciences LtdGandhinagar, IN14 days ago
Job descriptionEstablish and maintain a robust Quality Management System (QMS) to comply with ICH, USFDA, EMA, MHRA, OECD-GLP and cGMP 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. Provide Quality oversight for tech transfer activities from R&D to the manufacturing plant, ensuring QbD principles and regulatory expectations are met. Partner with Process R&D and Manufacturing teams to assure scale-up and commercial production quality . 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. 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. Identify and proactively manage quality risks across R&D and manufacturing. Introduce digital tools, analytics and automation to improve compliance, efficiency and decision making. 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, cGMP). Proven success in leading multi-location QA teams , managing customer and regulatory inspections, and implementing robust QMS. 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.
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
R&D & Manufacturing Interface
Plant Quality Assurance
People & Culture
Risk Management & Continuous Improvement
Qualifications & Experience
Key Competencies
Reporting Line
Reports to : Global Head of Quality
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Head Quality • Gandhinagar, IN
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