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, with a focus 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: assessing investigations, ensuring 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 preventative 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, in order 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
- Extensive and demonstrable experience in GCP Quality Assurance within clinical trials, including expert knowledge of CAPA management, ICH-GCP guidelines, and global regulations governing the conduct of clinical research studies.
- Prior audit and inspection management/support experience within a GCP-regulated clinical trials environment is required. Experience limited to GMP, manufacturing, laboratory, or commercial quality environments will not be considered.
- Hands-on experience conducting root cause analyses and quality investigations related to clinical trial activities conducted under GCP requirements.
- Proven experience reviewing, authoring, managing, and driving CAPAs to closure within a GCP clinical research environment.
- Strong understanding of the end-to-end clinical trial lifecycle, including sponsor, CRO, investigator site, vendor, and regulatory oversight activities under GCP.
- Demonstrated experience managing complex quality and compliance issues arising from clinical trial operations with minimal supervision.
- Bachelor's Degree in a Life Sciences, Healthcare, Pharmacy, Nursing, or related scientific discipline.
- Excellent problem-solving, risk assessment, and root cause analysis skills within a clinical research/GCP setting.
- Proven ability to train, mentor, and advise stakeholders on GCP quality and compliance requirements.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.
