Chief Quality Manager

The Head of Quality will provide end-to-end leadership of the quality function across discovery and process research R&D centres and 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 manufacturing.
  • 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 a 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, or 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