The Senior Director of Quality Assurance is responsible for implementing, in cooperation and agreement with the Global Quality Services team, quality assurance and quality control systems with written SOPs to ensure that clinical trials are conducted, and data are generated, documented, and reported in compliance with the protocol, GCP and the applicable regulatory requirements. The position may be assigned responsibility for line management and oversight of Quality Assurance Auditor personnel and or may be assigned additional specialty auditing and compliance oversight responsibilities. This may include areas of compliance expertise in Pharmacovigilance, Good Distribution/GMP expertise in a region, oversight of centralized Quality Event and CAPA management, Key Client/Quality Agreement Oversight, oversight of the QMS, and or Vendor Management oversight responsibilities. The focus of the position is to develop, perform and manage, in cooperation with the Global Quality Services team, all Quality Assurance-related activities such as internal GCP auditing, conduct of contracted GCP audits, GCP/GXP vendor compliance, Quality Event, and CAPA management and contributing to the development of an effective Quality Management System.
Responsibility to supervise, provide work direction, manage and support assigned quality assurance auditor personnel as a line manager or as applicable to assigned audit programs or tasks. Carries out supervisory responsibilities in accordance with the organization's policies and applicable local laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; performance management; addressing complaints and resolving problems.