Head of Quality

Job Title:

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

Location: Panoli, Gujarat, India

Position Summary

Head – Quality

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

Global Head of Quality