Group Lead-Development Quality Assurance

Quality Strategy and Leadership

Develop and implement a comprehensive quality assurance (QA) strategy for product development activities. Align QA processes with organizational goals regulatory requirements and industry standards. Drive initiatives to improve QA processes in product development ensuring efficiency and compliance. Collaborate with R&D manufacturing regulatory and clinical teams to integrate quality principles into development activities. Serve as a subject matter expert on QA in development providing guidance to cross-functional teams.

Regulatory Compliance Ensure all development processes comply with relevant regulations (e.g. FDA EMA ISO ICH guidelines).Stay updated on industry trends regulatory changes and best practices to enhance the organizations QA framework. Ensure compliance with Good Clinical Practices (GCP) Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) as applicable.

Inspection Readiness Prepare the organization for regulatory inspections or customer audits related to development processes. Lead audits and inspections conducted by regulatory bodies or clients for Product development functions. Address and resolve any findings or non-conformances identified during audits or inspections.

Risk Management and QMS Establish and maintain a robust quality management system (QMS) specific to the development lifecycle. Monitor all stages of product development to ensure adherence to quality standards. Review and approve development protocols reports and other critical documents (e.g. validation reports design specifications).Identify quality risks in the development process and implement mitigation strategies. Establish processes for change management and deviation handling during development.

Team Leadership and Development Provide training and support to teams on quality standards and and manage a high-performing QA team focused on development activities. Mentor and train QA staff ensuring they remain updated on regulatory and industry requirements.

Data and Documentation Integrity Ensure proper documentation and record-keeping practices for all development activities. Oversee data integrity initiatives to ensure accuracy completeness and reliability of development data.

Vendor and Partner Management Qualify and oversee external partners vendors and contractors involved in product development. Ensure external stakeholders meet the organizations quality standards and regulatory requirements.

Qualifications :

Qualifications : A Post-Graduate with at least  15 years of experience or PhD with at least 10 years of experience of cross functional experience  (fine balance of experience in Generalist and Specialist roles) with experience in development /manufacturing in biopharmaceutical industry

Range of Years of Experience : 15 years
Must Have Exposures / Experiences : cGMP GLP Regulatory and In-depth understanding of bio-pharmaceutical product development and production processes.

Business Understanding : Holistic understanding of integrating GLP and GMP in the regulatory landscape

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.
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 900000 patients having benefited from our products till date.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys 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. 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. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were 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  Work :

No

Employment Type :

Full-time