Lead Associate, Quality Audits

Role Summary

We are looking for a seasoned Lead Associate, Quality Audits who will conduct assessments on company sites, internal GMP departments, external partners, and quality systems to ensure compliance with regulatory requirements and company policies. The role supports readiness for regulatory inspection and collaborates across the regional organization to participate in cGMP and GDP compliance initiatives and continuous improvement. The position reports to the Lead, Quality & Compliance.

Responsibilities

• Maintain and enhance the supplier management process using quantitative methods to identify high-risk suppliers.
• Conduct detailed assessments of manufacturing processes, quality control procedures, and documentation systems to ensure compliance with established standards.
• Identify areas for process improvement and recommend corrective actions to enhance efficiency and quality outcomes.
• Conduct audits of external suppliers and vendors to assess their adherence to quality standards.
• Prepare comprehensive audit reports detailing findings, observations, and recommendations for improvement.
• Drive the implementation of quality improvement initiatives based on audit findings and industry advancements.
• Conduct thorough assessments of potential vendors‚Äô quality systems, capabilities, and processes to ensure alignment with organizational quality standards.
• Plan and execute audits of vendors‚Äô quality management systems, manufacturing processes, and facilities to ensure regulatory compliance and industry standards.
• Regularly monitor and analyze vendor performance data to identify trends and potential issues.
• Communicate quality expectations and vendor-related updates to internal stakeholders, ensuring alignment across the organization.
• Maintain Regional Supplier Qualification Reports and Audit Reports; prepare and manage Approved Vendors.
• Support regulatory compliance oversight of Dr. Reddy‚Äôs North America business and identify areas for correction to eliminate compliance gaps.
• Conduct proactive research of new and upcoming regulations and guidelines.
• Support the Regional Quality Council, coordinate compliance metrics for North America, and provide periodic updates to Executive Management.
• Prepare, revise, and execute quality agreements with all vendors in the quality system.
• Travel domestically and internationally may be required.

Qualifications

• Educational Qualification: M.S. in Chemistry, Biology or other life sciences; Auditing Certification preferred.
• Minimum Work Experience: 8+ years of progressive experience in auditing pharmaceutical or medical device systems, including 2 years of internal and external audit management experience.

Skills

• Strong understanding of pharmaceuticals, with experience in combination product or medical device manufacturing, packaging and testing processes, and 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 SOPs, summaries, investigation reports, audit reports, and technical change control.
• Must be a U.S. citizen or lawful permanent resident of the U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.

Education

• MS in Chemistry, Biology or other life sciences; Auditing Certification preferred.

Additional Requirements

• Travel domestically and internationally may be required.