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 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.
R&D & Manufacturing Interface
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 .
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, cGMP).
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

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