Lead Clinical Quality

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

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Role Purpose

The Lead – Clinical QA is responsible for driving end‑to‑end clinical quality oversight for biosimilar clinical development programs. The role ensures robust compliance with global regulatory expectations (USFDA, EMA, CDSCO, ICH) and Good Clinical Practice (GCP) across all clinical trial activities, including bioanalytical components. The position plays a critical leadership role in inspection readiness, audit governance, Quality Management System (QMS) maturity, and continuous improvement of clinical quality processes.

Key Responsibilities

1. Clinical Quality Oversight & Regulatory Compliance

• Provide strategic quality oversight for biosimilar clinical trials to ensure compliance with GCP, applicable global regulations, and internal quality standards.
• Act as the primary Quality partner to Clinical Development, Regulatory Affairs, Bioanalysis, Data Management, and external partners (CROs, vendors).
• Ensure clinical quality systems and processes are inspection-ready at all times.

2. Audit Strategy & Governance

• Develop and lead a global, risk‑based audit strategy for biosimilar clinical programs, including investigator sites, CROs, bioanalytical laboratories, and vendors.
• Design and maintain the functional Clinical QA audit program, aligned with regulatory expectations and biosimilar development risks.
• Prepare annual and project-specific audit plans covering clinical studies, systems, and processes.

3. Audit Execution & Lifecycle Management

• Plan, conduct, report, and close audits of:
  • Investigator sites
  • Contract Research Organizations (CROs)
  • Bioanalytical laboratories
  • Other clinical service providers
• Ensure timely issuance of audit reports and effective follow-up through closure of observations.
• Review, challenge, and approve Corrective and Preventive Action (CAPA) plans to ensure they are root-cause driven, sustainable, and effective.

4. Clinical Documentation & Quality Reviews

• Conduct independent quality review of:
  • Clinical protocols and protocol amendments
  • Clinical Study Reports (CSRs)
  • Tables, Figures, and Listings (TFLs)
  • Other essential clinical and regulatory documents
• Ensure data integrity, traceability, and consistency across clinical documentation supporting biosimilar submissions.

5. Inspection Readiness & Health Authority Engagement

• Lead inspection-readiness activities for Health Authority inspections (USFDA, EMA, MHRA, CDSCO, etc.).
• Actively support inspection conduct, including preparation of response strategies, coordination of inspection rooms, and management of inspection findings.
• Lead or contribute to development of inspection responses and corrective action commitments.

6. Quality Management System (QMS) Leadership

• Build, maintain, and continuously improve the Clinical Development QMS, ensuring alignment with regulatory requirements and biosimilar development complexity.
• Identify required clinical processes, procedures, and work instructions; ensure effective implementation and lifecycle management.

7. Metrics, Reporting & Continuous Improvement

• Develop and maintain clinical quality metrics, dashboards, and trend analyses to provide management visibility on quality performance, risks, and compliance status.
• Use audit and inspection trends to identify systemic improvement opportunities and preventive actions.

8. Training & Capability Building

• Identify GCP and role‑specific training needs across Clinical Development and supporting functions, in consultation with functional heads.
• Support development and rollout of targeted quality and compliance training programs.

9. Vendor Oversight & Systems Enablement

• Maintain and govern the clinical vendor management database, ensuring qualification, performance tracking, and compliance.
• Provide QA oversight and support for implementation and ongoing maintenance of clinical systems, including Data Management Systems (DMS) and related platforms.

Key Stakeholders

• Clinical Development & Clinical Operations
• Regulatory Affairs
• Bioanalytical & Data Management teams
• CROs and clinical vendors
• Global Quality & Compliance teams
• Health Authorities during inspections
  
  

Educational Qualification

A Post-Graduation in Sciences, Pharmaceuticals or Engineering

Minimum Work Experience

10 to 14 years of experience in various functions such as Manufacturing, Quality Control, Quality Assurance, Engineering, Research and Development in pharmaceutical and biopharmaceutical industries

Skills & Attributes Technical Skills:

• Strong comprehension of Quality Systems and Understanding of counter functions within the organization and their relationship to quality processes.
• Familiarity with quality assurance processes and methodologies.
• Deep understanding of cGMP (Current GMP) across various phases of the product life cycle.
• Knowledge of quality management principles and practices, including quality control and quality assurance.
• Broad understanding of the development and production processes, and equipment and utilities required within the pharmaceutical manufacturing and quality control.
• In-depth knowledge of both the products and the processes involved in the Bio Pharma and Pharma sectors.
• Proficient auditing skills, and an understanding of national and international regulatory guidelines relevant to the pharmaceutical industry.

Behavioural Skills:

• Strong communication and influencing skills.
• Commitment to continuous learning and coaching.
• Displays risk-based decision-making skills.
• Excels in building and leveraging relationships, with a focus on strong team-building.
• Commitment to innovation and effective problem-solving.
• Prioritizes integrity in all aspects of work.
  
  

About the Department

Biologics

Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon...

Benefits Offered

At Dr. Reddy’s, we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards...

Our Work Culture

Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions...

For more details, please visit our career website at https://careers.drreddys.com/#!/