Sr. Director, Quality Assurance - (R1046677) in Research Triangle Park, NC at IQVIA™

Date Posted: 11/10/2018

Job Snapshot

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Description


Purpose:

The Senior Director, CAPA Center of Excellence is responsible for providing strategic and tactical leadership for all aspects of corrective and preventative action (CAPA) processes related to good GCP and PV Quality Issues, ensuring that these processes are compliance with regulatory requirements and industry expectations, and optimizing these processes for efficiency, impact and scalability.   This is a highly visible and important position within QA, and because of the subject, has enterprise-wide impact.  It requires both strategic vision and personal tactical execution.


Summary of Responsibilities:

  • Oversees the development and implementation of relevant processes related to CAPA GCP/PV quality procedures, governance, track relevant metrics of CAPA process performance, and training programs for functional CAPA champions to drive efficiency and impact of CAPAs. 
  • Serves as the Key Core Process owner for QI/CAPA processes. Delivers an effective, pragmatic governance structure to ensure development and implementation of sustainable CAPAs that drive value to the business with emphasis on efficiency, impact and scalability.
  • Ensures appropriate and ongoing functional and program-level oversight of QI and CAPA.
  • Collaboration with QA BA&DS team to aggressively utilize CAPA metrics to develop impactful interventions to improve the efficiency, impact and scalability of CAPAs
  • Collaborates with quality partners to ensure that an appropriate link between preventive actions and the management of risk.
  • Oversees staff in developing and delivering training programs designed to increase employee awareness and knowledge of QI and CAPA and in developing and supporting QI/CAPA Owners regarding the QI/CAPA processes, CAPA best practices, and CAPA record content.
  • Serves as a strategic partner to internal and external business partners in driving innovative approaches for issue management within clinical development and credible thought leadership regarding CAPA processes.
  • Ensures appropriate resources to execute the programs compliantly, effectively and efficiently.
  • Develops internal talent through cost-efficient educational and developmental activities that enhances the succession-planning process.  
  • Manages staff performance, utilization, efficiency and revenue recognition
  • Performs other related duties as assigned.


Job Requirements


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 


 Required Education and Experience:
  • Bachelors degree in a scientific or healthcare-related field.
  • Demonstrated experience leading and successfully delivering on high-profile quality initiatives with senior executive leadership visibility.
  • Minimum 5 years of experience in experience in clinical quality in a pharmaceutical, biotech, or other regulated industry. 
  • 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.  
  • Prior line management experience 


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


We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.


Job ID: R1046677