High Salary 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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