Lead Clinical QA

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.

Job summary
We are seeking a qualified professional to spearhead the establishment and supervision of quality management systems in clinical development. This role involves strategic planning and execution of audits, ensuring adherence to GxP (General Accepted Practices) standards, and driving quality assurance initiatives across diverse systems. Your expertise will play a pivotal role in maintaining high-quality standards and compliance within the clinical development domain.

Roles & Responsibilities
• You will be responsible for supporting the strategic development of a global risk-based audit strategy and program for clinical trials. This includes performing and reporting audits of investigator sites, clinical research organizations, and sponsors, conducting quality reviews of protocols and reports, and overseeing external site and vendor audits.
• You will review, evaluate, and approve proposed corrective and preventive action plans (CAPA), develop functional audit plans to check adherence to various regulatory requirements, and devise metrics and dashboards to provide an overview to the management.
• You will be responsible for hosting local and global Health Authority (HA) inspections, including preparation and execution of inspection readiness exercises in clinical development. Additionally, you will review and align on the final Corrective and Preventive Action (CAPA) in response to regulatory inspections.
• Key aspects of your role will include maintaining a database of reported quality issues, running audit metrics, supporting operational teams in root cause analysis for non-compliances, building and maintaining the Quality Management System of Clinical Development, and drafting QA (Quality Assurance) SOPs (Standard Operating Procedures), along with reviewing and providing inputs for functional SOPs.
• You will be responsible for identifying training needs, tracking compliance, managing learning management systems, maintaining vendor management database, and identifying and qualifying vendors for clinical development.
• Your role will also include supporting implementation and continual maintenance of Data Management System (DMS), assisting in the management of controlled documents, and overseeing archive processes, including vendor selection for archival document maintenance.

Educational qualification: A Bachelor/ Master’s degree, with a background in a relevant scientific field

Minimum work experience : 4-7 years of experience in conducting clinical trial audits (Phase I, Phase III studies and post marketing studies), pharmacovigilance audits, GCLP (Good Clinical Laboratory Practice) audits, various types of vendor audits, quality issue management and root cause analysis; Relevant experience in developing QMS (Quality Management System) and handling regulatory inspections is necessary.

Skills & attributes:

Technical Skills
• Understanding of overall drug development processes, with a specific emphasis on biologics, is preferable.
• Familiarity with technology platforms and delivery systems relevant to biologics and clinical development, combined with a solid understanding of quality management as well as the global regulatory framework, including regulatory requirements for clinical trials.

Behavioural skills
• Strong negotiation skills and cross-cultural sensitivity for collaborating with diverse teams and stakeholders, especially in a global regulatory environment.
• Objectivity for impartial decision-making and the ability to work in a dynamic environment.
• Ability to align cross-functional teams and an execution oriented mind set for successful implementation.

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.
With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.

Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

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. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at https://careers.drreddys.com/#!/