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Lead Quality Assurance and Regulatory Affairs Specialist

2 months ago

Princeton, New Jersey, United States Dr. Reddy's Laboratories Full time
Job Summary

Dr. Reddy's Laboratories is seeking a highly skilled and experienced Director of Quality Systems and Compliance to lead our quality management system and ensure compliance with regulatory requirements.

Key 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, and approve QMS procedures and processes to ensure alignment with regulatory requirements.
  • 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 laboratory investigations generated by external partner sites for Dr. Reddy's products manufactured at external sites.
  • Prepare the Princeton facility for regulatory inspections and host inspections as needed.
  • 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 and analyze data to identify risks and drive implementation of mitigation plans.
  • Build relationships with internal and external partners to ensure effective collaboration and communication.
  • 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 management in North America as part of quality review meetings.
Qualifications and Skills
  • Bachelor's or Master's degree 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.