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Dr. Reddy's Laboratories · 1 day ago

Lead Associate, Quality Audits

Princeton, NJ

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

Dr. Reddy's Laboratories is dedicated to making breakthroughs in healthcare and improving people's lives. They are seeking a seasoned Lead Associate in Quality Audits to ensure compliance with regulatory requirements and enhance quality systems through assessments and audits.

BiotechnologyHealth CareMedical

No H1B

U.S. Citizen Only

Responsibilities

You will be responsible for maintaining and enhancing the Supplier management process using quantitative methods to identify high-risk suppliers

You will be responsible for conducting detailed assessments of manufacturing processes, quality control procedures, and documentation systems to ensure compliance with established standards

You will be responsible for identifying areas for process improvement and recommending corrective actions to enhance efficiency and quality outcomes

You will be responsible for conducting audits of external suppliers and vendors to assess their adherence to quality standards

You will be responsible for preparing comprehensive audit reports detailing findings, observations, and recommendations for improvement

You will be responsible for driving the implementation of quality improvement initiatives based on audit findings and industry advancements

You will be responsible for conducting thorough assessments of potential vendors’ quality systems, capabilities, and processes to ensure alignment with organizational quality standards

You will be responsible for planning and executing audits of vendors’ quality management systems, manufacturing processes, and facilities to ensure compliance with relevant regulations and industry standards

You will be responsible for regular monitoring and analyzing vendor performance data to identify trends and potential issues

You will be responsible for communicating quality expectations and vendor-related updates to internal stakeholders, ensuring alignment and understanding across the organization

You will be responsible for maintaining Regional Supplier Qualification Reports and Audit Reports. You will prepare and manage Approved Vendors

You will be responsible for supporting regulatory compliance oversight of Dr. Reddy’s North America business and identifying areas for correction to eliminate compliance gaps

You will be responsible for proactive research of new and upcoming regulations and guidelines

You will be responsible for supporting the Regional Quality Council, coordinating compliance metrics for North America and providing periodic updates to Executive Management

You will prepare, revise, and execute quality agreements with all vendors in the quality system

You may be required to travel domestically and internationally

Qualification

Auditing CertificationGMP RegulationsQuality Management SystemsPharmaceutical KnowledgeTechnical WritingCommunication SkillsOrganizational SkillsAttention to DetailTime Management

Required

M.S. in Chemistry, Biology or other life sciences

8+ years of progressive experience in auditing pharmaceutical or medical device systems, including 2 years of internal and external audit management experience

Strong understanding of pharmaceuticals, with a combination product or medical device manufacturing, packaging and testing processes, and management of Quality Management Systems

Thorough understanding and familiarity with auditing, GMP regulations, including 21 CFR 210, 211, 111, 820, ICH guidelines, IPEC guidelines, FDA guidance documents

Understanding of QMS in pharmaceutical manufacturing and packaging facilities and excipients manufacturers

Excellent verbal and written communication skills

Excellent organizational and time management skills

Strong attention to detail

Strong writing skills for creating technical documents such as Standard Operating Procedures, Summaries, investigation reports, audit reports, and technical change control

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