Clinical Quality Assurance Lead

4 weeks ago

Hyderabad, Telangana, India Dr Reddy's Laboratories Limited Full time

Job Summary

We are seeking a highly skilled professional to lead the establishment and supervision of quality management systems in clinical development. This role involves strategic planning and execution of audits, ensuring adherence to GxP standards, and driving quality assurance initiatives across diverse systems.

Key Responsibilities

  • Support the development of a global risk-based audit strategy and program for clinical trials, including performing and reporting audits of investigator sites, clinical research organizations, and sponsors.
  • Review, evaluate, and approve proposed corrective and preventive action plans (CAPA), develop functional audit plans to check adherence to regulatory requirements, and devise metrics and dashboards to provide an overview to management.
  • Host local and global Health Authority (HA) inspections, including preparation and execution of inspection readiness exercises in clinical development, and review and align on the final Corrective and Preventive Action (CAPA) in response to regulatory inspections.
  • Maintain a database of reported quality issues, run audit metrics, support operational teams in root cause analysis for non-compliances, build and maintain the Quality Management System of Clinical Development, and draft QA SOPs, along with reviewing and providing inputs for functional SOPs.
  • Identify training needs, track compliance, manage learning management systems, maintain vendor management database, and identify and qualify vendors for clinical development.
  • Support implementation and continual maintenance of Data Management System (DMS), assist in the management of controlled documents, and oversee archive processes, including vendor selection for archival document maintenance.

Qualifications

A Bachelor/ Master's degree, with a background in a relevant scientific field, and a minimum of 4-7 years of experience in conducting clinical trial audits, pharmacovigilance audits, GCLP audits, vendor audits, quality issue management, and root cause analysis. Relevant experience in developing QMS and handling regulatory inspections is necessary.

Skills and Attributes

Strong negotiation skills and cross-cultural sensitivity for collaborating with diverse teams and stakeholders, objectivity for impartial decision-making, and the ability to work in a dynamic environment. Familiarity with technology platforms and delivery systems relevant to biologics and clinical development, combined with a solid understanding of quality management and the global regulatory framework, including regulatory requirements for clinical trials.

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