Head of Quality

3 weeks ago


Gujarat India, India PI Health Sciences Ltd Full time

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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