Position Details
Job Title: Lead Associate – Quality Audits
Department: Quality & Compliance
Location: North America (U.S.)
Job Type: Full-time | On-site | Quality Function
Reporting To: Lead, Quality & Compliance
Travel Requirement: Domestic and International travel may be required
Eligibility: Must be a U.S. citizen, lawful permanent resident, or otherwise authorized to work in the U.S. without sponsorship
Company Description
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company headquartered in India with a global presence across 66 countries. With over 24,000 employees, our purpose is to accelerate access to affordable and innovative medicines—because Good Health Can’t Wait.
For four decades, we’ve stood for access, affordability, and innovation, grounded in deep science, progressive people practices, and strong corporate governance. As we evolve, we focus on “The Next and The New”—strengthening our core businesses and building sustainable innovations for the future.
We aim to reach 1.5+ billion patients worldwide by 2030, integrating sustainability at the core of our strategy—respecting people, planet, and purpose.
Dr. Reddy’s is proud to be an Equal Opportunity Employer, fostering a diverse, inclusive, and discrimination-free workplace.
Job Summary
The Lead Associate, Quality Audits will be responsible for conducting assessments across internal GMP departments, external partners, and quality systems to ensure compliance with regulatory requirements, standards, and company policies. The role supports regulatory inspection readiness, quality improvement initiatives, and cGMP/GDP compliance activities within the North America region.
Key Roles & Responsibilities
Audit Management & Compliance
Conduct detailed audits and assessments of manufacturing processes, quality control systems, and documentation for compliance with cGMP/GDP and company policies.
Lead supplier management process using risk-based assessment tools to identify high-risk vendors.
Prepare comprehensive audit reports, documenting findings, observations, and recommendations.
Drive implementation of Corrective and Preventive Actions (CAPA) based on audit findings.
Support regulatory inspection readiness and ensure ongoing adherence to quality standards.
Supplier & Vendor Oversight
Conduct audits and evaluations of external suppliers, vendors, and third-party manufacturers.
Develop, maintain, and update supplier qualification and audit reports.
Manage quality agreements with all vendors in the quality system.
Monitor vendor performance trends and ensure alignment with company quality expectations.
Quality System Improvement
Identify process improvement opportunities and recommend corrective actions.
Support regulatory compliance oversight and proactively address potential compliance gaps.
Collaborate with cross-functional teams (Quality, R&D, Manufacturing, Supply Chain) to ensure continuous improvement.
Regulatory & Industry Interface
Maintain awareness of evolving global regulations, standards, and guidelines (FDA, ICH, IPEC).
Support the Regional Quality Council by coordinating compliance metrics and preparing updates for Executive Management.
Qualifications
Educational Qualification
M.S. in Chemistry, Biology, or Life Sciences (required)
Auditing Certification (preferred)
Work Experience
Minimum 8+ years of progressive experience in pharmaceutical or medical device auditing, including 2+ years of internal/external audit management.
Skills & Competencies
Strong knowledge of pharmaceutical and medical device manufacturing, packaging, and testing processes.
In-depth understanding of GMP regulations (21 CFR 210, 211, 111, 820), ICH, and IPEC guidelines.
Experience with Quality Management Systems (QMS) in manufacturing and packaging environments.
Excellent written and verbal communication skills.
Strong analytical, organizational, and project management capabilities.
Proficiency in preparing audit reports, SOPs, investigation summaries, and technical documentation.
Exceptional attention to detail and problem-solving skills.
Additional Information
Work Culture
At Dr. Reddy’s, our credo “Good Health Can’t Wait” reflects our commitment to improving patients’ lives through empathy, innovation, and collaboration. We believe in empowering people, fostering teamwork, and creating an environment where diverse skills and perspectives lead to shared success.
Equal Opportunity Statement
Dr. Reddy’s Laboratories Ltd. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.
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