Lead - Clinical Quality

Company Description 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 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 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