Head of Quality Assurance

Job Title:

Head – Quality Assurance (India Operations: R&D & Manufacturing)

Location: Panoli, Gujarat, India

Position Summary

The
Head – Quality Assurance
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