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