Lead Associate - Analytical Quality and Compliance

Lead Associate Analytical Quality and Compliance

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.

Job Description

North America business group seeks to hire Lead Associate, Analytical Quality and Compliance, based in Hyderabad office, the incumbent will provide an independent oversight of Analytical Quality and Compliance for Quality Control across North American Internal and External sites in alignment with federal regulatory requirements. You will provide direction, support and guidance to ensure effective use of Analytical Quality Control procedures, policies and systems, assuring compliance and Improvement of key GXP processes, audit readiness and risk management to ensure reliable supply of consistent quality of pharmaceutical products in the US and Canada market.

Responsibility:
Manage regional Internal & external laboratory audits, supplier quality management, analytical change management, change control process, and the stability program. Conduct laboratory GAP assessments and provide laboratory compliance expertise.

• Provide analytical quality oversight for analytical change management and laboratory change control processes
• Provide quality leadership for analytical quality control projects and base business support to ensure compliance with the organizational and regulatory standards
• Provide oversight for nitrosamine risk assessment, analytical testing strategies, method validation/verification, and regulatory commitments, in alignment with FDA and Health Canada expectations
• Provide quality oversight and review of Annual Product Quality Reviews (APQRs/PQRs) from an analytical and laboratory compliance perspective
• Ensure laboratory trends, OOS/OOT events, method performance, stability data, and investigation outcomes are appropriately assessed, justified, and documented within APQRs
• Identify systemic laboratory and analytical risks through APQR trending and ensure linkage to CAPA and continuous improvement initiatives
• Review and approve laboratory investigations (OOS, OOT, deviations, atypical results), ensuring root cause analyses are scientifically sound, data‑driven, and inspection‑ready
• Ensure effective data review and data integrity controls across the North America region with timely resolution of findings and observations
• Support regulatory response strategies related to laboratory investigations and data integrity observations
• Ensure effective governance of the stability program, including protocol compliance, trending, OOT/OOS management, and risk escalation
• Provide guidance for product robustness, deploy training of regional quality control procedures in collaboration with Business unit quality groups
• Ensure Data review controls across North America region including inspection readiness and resolutions
• Support resolution of analytical, laboratory, and compliance issues at other Dr. Reddy’s Laboratories sites, as needed, including support during regulatory inspections and for-cause investigations

Qualifications

• A minimum of a bachelor's degree (chemistry/ microbiology, or science) is required.
• 7+ years of experience in a Quality Assurance/Quality Control role in Bio-Pharmaceutical regulated environment.
• Experience and working knowledge in Analytical R&D quality, quality control/QA and related quality systems.
• Supervisory experience and sound knowledge of Quality Control, data integrity and data review experience.
• Proven record in support of GMP Quality control and Analytical R&D quality.
• Knowledge of Quality Risk Management principles.

Additional Information

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/#!/ 

Experience Level

Entry Level