Job Overview
Lead and support effective corrective and preventive action (CAPA) management for significant quality issues (QIs) and audit and inspection responses including the assessment and review of investigations, appropriate root cause analysis and corrective and preventative actions. Provide support to management with insights, analyses and assessment and promotion of compliance with regulations, guidelines, and operating procedures through risk identification and mitigation, and improvement initiatives. Manage the quality assurance oversight of quality issues, audit responses, assignments, training and staff. Oversee and lead team management activities.
Essential Functions
* Lead and mentor members of the CAPA management team, focusing on driving improvement and compliance, ensuring an aligned approach to CAPA management and adherence to regulations and guidelines and providing support as needed.
* Lead and support CAPA activities for complex QIs and sponsor audits and inspections: assess investigations, ensure appropriate root cause analysis is performed, adequate corrective and preventative actions and effectiveness are implemented and followed up within the agreed timelines.
* Collaborate with cross-functional stakeholders to identify process gaps, areas of improvements and ensure the application of quality processes, principles and strategy to support compliance with relevant regulations, GCP guidelines, procedures and sponsor agreements.
* Ensure proper reporting and documentation of CAPAs in the electronic quality management system (eQMS) and that robust corrective and preventive actions and effectiveness checks are tracked and completed within the required timelines.
* Promote a culture of proactive and continuous process improvement by identifying risks and trends, and optimizing the CAPA system and processes.
* Lead with a spirit of teamwork and collaboration to ensure effective communication among all department stakeholders and staff.
* Develop and/or provide training and guidance on Root Cause Analysis (RCA), CAPA management, execution, good documentation practices, and compliance adherence.
* Develop and/or improve governing procedures, templates and work instructions, to streamline processes and drive compliance.
* Advise Quality Assurance management on system audit needs.
* Support external and internal audits and inspections of IQVIA including inspections of IQVIA or investigational sites where needed, and ensure a state of inspection readiness at all times.
Qualifications
* Bachelor's Degree
* 7 years Quality Assurance experience in pharmaceutical, technical, or related area with a focus on GCP and/or GPVP in Clinical Trials.
* Background in science, healthcare and/or other relevant discipline and a detailed understanding of the clinical trial process and GCP guidelines.
* Extensive knowledge of CAPA Management, GCP guidelines and relevant regulations for the conduct of clinical trials.
* Strong leadership and organizational skills for prioritizing workload and responsibilities.
* Excellent verbal and written communications with ability to effectively communicate at multiple levels in the organization and successfully liaise with cross-functional teams.
* Excellent problem solving and root cause analysis skills.
* Excellent training and mentoring capabilities.
* Ability to handle multiple projects and work independently and effectively in a fast‑paced changing environment.
* Ability to speak effectively one-to-one, in group settings, with clients, vendors and employees of the organization.
* Proficient in Microsoft Office applications (Word, Excel).
Visa Information
This role is not eligible for UK visa sponsorship.
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