Lead Associate, Quality Investigations

At Dr. Reddy's "Good Health Can't Wait" 
By joining Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community. 

Diversity, Equity & Inclusion 
At Dr. Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team.  We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background.  

We are seeking an exceptional investigator to join us as Lead Associate, Quality Investigations in our Princeton, NJ office. This role will report to Lead Quality Systems. The Lead Associate, Quality Investigations is responsible for conducting thorough investigations into quality-related issues, ensuring compliance with regulatory requirements, and driving continuous improvement in Quality Assurance processes. This role will serve as a key point of contact for internal and external groups, supporting root cause analysis and corrective actions to maintain high-quality standards.

Responsibilities: 

• Ensures all Dr. Reddy’s NAG partners comply with GMP’s.

• Ensures Data Integrity and Data Review controls and improvement efforts across the North America region.

• Lead and conduct detailed quality investigation reviews and approvals related to deviations, non-conformances, and customer complaints.

• Reviews, supports, escalates and approves critical laboratory and operations investigations with potential to affect product availability.  

• Provides Quality support related to Analytical and Operations issues, Laboratory and Manufacturing investigations, Product Specifications, Analytical Method Validation, Process Validation, Method and process Transfer and major Change Controls for commercial and products under development are reviewed by QA in a timely manner. 

•  Perform root cause analysis using structured methodologies.

• Collaborate with internal cross-functional teams and external business partners to develop and implement corrective and preventive actions (CAPAs), including batch disposition for quality-related issues.

•   Ensure compliance with industry regulations, company policies, and quality standards.

• Maintain accurate documentation of investigations and communicate findings effectively.

• Maintain the Partner Quality Index and capture internal KPIs.

• Trends, escalates issues to ensure method and product robustness based on monitoring of trend data.  

•  Reviews Analytical method and process development, enhancements and validation/verification, transfer related documents and raw data generated at DRL internal and contract organizations.

• Support internal and external laboratory and operations Audits, supplier quality management. 

•  Support audits and inspections by providing necessary documentation and responses.

•  Drive continuous improvement initiatives to enhance quality processes and minimize risks.

• Provide training and guidance to team members on investigation procedures and best practices.

Educational qualification: Bachelor’s Degree (or its U.S. equivalent) in Life Sciences, Pharmaceutical Sciences or a closely related field

Minimum work experience: 8+ years of experience in a pharmaceutical and/or biotech

Skills & attributes: 

• Strong knowledge in pharmaceutical manufacturing and/or Laboratory techniques; especially Chromatography (HPLC, GC), Dissolution and compendia test procedures.

• Strong knowledge of regulatory requirements (e.g., FDA, GMP, ISO).

• Proficiency in root cause analysis and problem-solving methodologies.

• Excellent communication, documentation, and analytical skills.

• Ability to work collaboratively in a fast-paced environment.

*Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future. 

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.

Equal Opportunity Employer 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. 

For more details, please visit our career website at https://careers.drreddys.com/#!/