Lead Clinical Quality

Responsible for overseeing quality systems and regulatory compliance across clinical trials involving biological products. This role ensures that all clinical research activities meet global regulatory standards internal policies and Good Clinical Practice (GCP) guidelines. The Lead will collaborate with cross-functional teams to drive inspection readiness audit strategy and continuous improvement in clinical quality.

Conduct of Audits: Development of Audit Plans for ongoing Project- Strategic development of an effective global risk-based audit strategy and program for clinical trials including bioanalysis. Development of a functional audit program. Development of a functional audit plan to check adherence of processes to various regulatory requirement.         

• Planning conduct reporting and closure of audits
• Perform and report audits of investigator sites clinical research organization and sponsor as per the audit program.                                                                                              
• Conduct of quality reviews of Protocol reports in addition to audit of tables figures and listings and other supplementary clinical trial documentation.
• Conduct external site and vendor audits and provide support in preparation review and finalization of audit reports.
• Review evaluate and approve proposed corrective and preventive action plans (CAPA)

Develop various metrics and dashboards to provide the management with an overview of the clinical development Quality .  

Provide inspection-readiness support and lead Health Authority inspection responses

Build and maintain the Quality Management System of Clinical Development including identification of processes required as per applicable regulations.     

Identification of training needs for the various roles in the function in consultation with the functional heads.

Maintenance of vendor management database.

Support for implementation of Data Management System (DMS) and continual maintenance                                                                                                                                       

Qualifications :

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.

Additional Information :

About the Department

Biologics

Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 1015-year time horizon...

Benefits Offered

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

Our Work Culture

Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions...

For more details please visit our career website at Work :

No

Employment Type :

Full-time