Director / Lead Quality Systems

Description Position at Dr. Reddy's Laboratories Inc
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 & InclusionAt 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.

Purpose:

The Lead Quality Systems will lead, execute and maintain QMS processes (Deviation, CAPAs, Change Control, Documentation & Training). Will be responsible to monitor QC, QA activities and other GMP functions of internal quality management system for compliance and provide oversight of external partners for thorough and timely closure of the Quality system elements in line with Dr.Reddy's procedures & regulatory requirements.Based in Princeton, NJ (Hybrid) this role will report to Head Quality - North America

Responsibilities:

• • Oversee and ensure the proper execution of key quality system elements such as records management, document control, change management, deviation management and CAPA
• • Review, revise, approve QMS procedures and processes
• • Assess current quality systems and recommend improvements to improve compliance and optimize processes
• • Manage the training program for the site and act as the site quality lead for data integrity initiatives
• • Ensure timely and thorough review of the laboratory investigations generated by external partner sites for the DRL products manufactured at external sites
• • Prepare the Princeton facility for any time inspection readiness and host the regulatory inspections
• • Lead the identification and resolution of quality issues including facilitation of investigation process and development of robust CAPA plans
• • Supervise quality performance of external partners through the development of key performance indicators; Analyze data to identify risks and drive implementation of mitigation plans
• • Build relationships with internal and external partners
• • Work directly with the Site Quality Head to deploy Regional Quality initiatives to the site, conduct gap assessments as needed and provide key input into the development of such initiatives
• • Lead risk management initiatives vital to improve performance and in support of supply chain to meet patient supply requirements
• • Collate quality and compliance metrics information and support presentation of relevant data to the management in North America as part of quality review meeting
• • Leads a high performance cross functional aligned team to deliver against targets and expectations

Qualifications / Skills:

• • B.S. or M.S. in a Chemistry, Biology, or other life science is preferred
• • 10+ years of experience managing quality systems or directly associated with analytical and/or manufacturing quality in pharmaceutical dosage form facilities
• • Experience managing quality events such as change controls, investigations, CAPA, documentation and training
• • Experience in preparation and execution of GMP regulatory inspections
• • Thorough understanding and familiarity with GMP regulations, including 21 CFR 210, 211 requirements, ICH and FDA guidance documents
• • Excellent attention to detail, and ability to consistently meet high standards of quality required in QA Compliance
• • Excellent verbal and written communication skills, organizational and time management skills
• • Ability to work with internal and external manufacturing sites in a matrix environment
• • Experience in setting clear and concise objectives and leading motivating teams

Able to travel 15% of the time - Domestic & International
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.COVID-19 VaccinationGetting vaccinated remains the most effective way to halt the spread of the COVID-19 pandemic, and Dr. Reddy's encourages all employees to be vaccinated. At this time, vaccinations are not mandated for Princeton-based employees but may become required in the future. Weekly COVID testing is mandatory for all employees who have not uploaded proof of vaccination or who are not fully vaccinated.

Equal Opportunity Employer:

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