Sr Director, Quality Investigations & CAPA

The IQVIA QA team is a dynamic, talented, and experienced global team that owns the global quality management system for the largest human data science company in the world. The QA function is responsible for driving compliance in a highly regulated industry through audits, functional support, issue & CAPA management, regulatory consultancy, management of data analytics and customer relationship interactions. These services ensure our clinical research activities are of the highest quality.  We proactively support our business partners and help to drive innovation.  Continuous improvement is a core capability and we value strategic thinking, creativity and operational excellence.  We seek highly motivated people who truly want to make a difference in the life sciences industry and are looking for opportunities to impact the business and be part of the solution. At IQVIA, we support our colleagues with a focus on succession planning, career progression and continuous learning.

Purpose:

This position will lead and drive the Quality Investigations & CAPA Center of Excellence function, as part of the Quality Management System within Global QA.  The role owns the process and lifecycle for the management of quality issues, inclusive of assessment, triage, investigation, and CAPA.  This role reports into the Global Head of Quality Assurance and is a member of the QA Leadership Team.  Responsibilities include the day-to-day management of activities, as well as identifying and driving process improvements.  The individual routinely interacts with executive leaders and business partners internally, as well as supports customer-facing interactions for Quality Investigations, CAPA, or trend analysis. 

Summary of Responsibilities

• The role will be responsible to drive process improvement and further development of the methodology, triage and tools used in the investigation of critical and major quality issues and audit findings.
• The individual will oversee the development of risk-based processes and tools to be used in conducting investigations, with an emphasis on developing cost effective, efficient solutions, and demonstrating the effectiveness and enhancements to support and continuously improve the Quality Management System.
• The role will ensure training is deployed to internal business partners on key topics such as:  good investigative techniques, methodology to identify root cause, identifying appropriate CAPA, drafting a well-constructed investigation summary, etc.
• The individual will be fully accountable for the management and oversight of Investigations and CAPA systems to ensure process is in place to support the identification of root cause and appropriate CAPA actions are both identified and implemented.  The individual will establish clear responsibility for oversight of investigations and proposed actions to drive improvements for the underlying processes and systems.
• The role will ensure adequate metrics, trends and dashboards are in place to monitor performance; identify trends; and will be responsible to disseminate or present these QA outputs both internally (business partners) and externally to clients.
• The individual is a member of the QA Leadership Team and will work alongside the leaders in the global QA team

Required Experience:

• Demonstrated experience leading and successfully and timely delivering on implementation of cross-functional initiatives and programs with senior executive leadership visibility.
• Demonstrated experience designing and implementing effective Quality Management Systems in a clinical trial and/or pharmacovigilance setting, with a focus on issue management.
• Broad experience in interpreting and applying relevant standards for GCP and GVP. Direct or indirect experience working with regulators on GCP- and/or PV-related issues preferred. 
• Minimum 5 years of experience in clinical development or pharmacovigilance in the pharmaceutical, biotech, or other regulated industry.
• Prior line management experience

Required Skills:

• Strong negotiation and influencing skills; demonstrated ability to work constructively and effectively at all levels across functions as well as with external customers.
• Demonstrable experience and ability to utilize analytics to make data-driven decisions and assess impact of interventions
• Self-motivated and able to work with limited direct supervision
• Collaborative and ability to work effectively in a matrix environment
• Strong project management skills, strategic mindset and demonstrated business acumen
• Demonstrated expertise in implementing successful process and continuous improvement efforts, yielding increased effectiveness and efficiency
• Expert knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
• Strong knowledge of the principles for a GCP Quality Management System, ICH Guidelines, FDA regulations, the EU Clinical Trial Regulation, EU Directives, MHRA Statutory Instruments, EMA PV requirements and other relevant laws, regulations, and guidance. 
• Superb and polished ability to consistently present information in a clear, compelling, and understandable format, tailoring presentations to the context and audience. 
• Highly professional and unflappable demeanor to effectively interact with senior internal leaders and external stakeholders

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.