Vipul Nayani

Associate Director, Quality Management Systems @Teva Pharmaceuticals

Leading the development, management, and improvement of the Quality Management System (QMS) to ensure compliance with applicable regulations and company procedures, in support of GMP commercial and clinical manufacturing, and bioanalysis activities. Managing personnel with subject matter expertise (SMEs) in auditing, deviations, CAPAs, supplier management, change controls, training compliance and document control Assuring compliance of local SOPs to corporate standards, actively contributing through authoring, reviewing and approving SOPs and corporate gap assessments. Providing direct oversight of the internal audit program, external inspection management, assuring compliance to regulation, corporate standards and local procedures. Managing external/health authority regulatory inspections (Pre-License, Routine) as lead contact/liaison Reviewing Quality Council data as member of site management review board Providing quality compliance oversight of the SAP and TrackWise system through identification, monitoring and trending of deviations, investigations, change control, and CAPAs per Quality Management System implementation. Providing quality compliance support to inspection readiness initiatives. Mentoring and training for activities that support GMP studies and clinical and commercial manufacturing. Developing and delivering quality systems training programs (Deviations, CAPAs, Change Controls) Maintaining up-to-date knowledge of regulatory guidance documents, regulations and trends relative to GMP and data integrity and incorporate into auditing and manufacturing processes. Reviewing standard operating procedures related to phase appropriate GMP for clinical site development and manufacturing activities for compliance with regulations, good documentation practices and compatibility to related SOPs. Leading and assisting the conduct and follow-up reporting of external inspections by regulatory authorities.