17718-Sr Dir, Quality Assurance - (R1041173) in Research Triangle Park, NC at IQVIA™

Date Posted: 9/27/2018

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/ROLE:


The QA General Manager, Americas and Audit is responsible for providing strategic and operational leadership for all aspects of GCP and PV audits, ensuring that audit activities are risk-informed and in compliance with regulatory requirements and industry best practices.  In addition, the incumbent provides strategic oversight of QA activities in the region and fosters a data-driven, solution-oriented culture that enables QA to be a valued business-partner for internal and external stakeholders. This is a highly visible and important position within QA, with enterprise-wide impact.  


RESPONSIBILITIES:
  • Drives regionally-based staff to deliver quality audit activities based on a data-driven, risk-informed decision-making approach 
  • Efficiently allocates resources, using a data-driven approach, to maximize the impact of QA and to deliver internal and contracted quality audits.
  • Works closely with regional functional business leaders and customers (or delegates to regional QA leaders) to build strong alliances, to drive continuous process improvements, ensure appropriate management of risks, identify and resolve quality issues, manage audits and inspections, and develop a culture of quality.
  • Provides expert-level guidance and credibility in quality matters in the region underpinned by a thorough understanding of GCP, PV, and other relevant quality compliance requirements of major regulatory agencies (e.g. FDA, EMA, PMDA, CFDA)
  • Applies proactive approaches to continuous improvement of the Quality of our internal processes. 
  • Employs scalable and sustainable reporting capabilities developed by the Business Analytics and Decision Support (BADS) group to maintain oversight of regional activities and provide data-driven QA guidance to stakeholders.  
  • Enhances  planning and delivery for management of audits and inspections to provide confidence to external auditors and inspectors. 
  • Develops internal talent through cost-efficient educational and developmental activities that enhances the succession-planning process.  
  • Manages staff performance, utilization, efficiency and revenue recognition
  • Develops a continuous learning, and process-improvement expectation within the region.

Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

  • Thorough understanding of GCP, PV, and other relevant quality compliance requirements of major regulatory agencies (FDA, EMA, PMDA) and demonstrated experience interpreting and applying relevant regulations, laws and guidance. Direct or indirect experience working with regulators on GCP-and/or PV-related issues preferred.   
  • Effective change management including development of a continuous learning culture, accountability and process-improvement
  • Demonstrated financial and business acumen and efficiency improvement (e.g. Lean)
  • Collaborative stakeholder engagement with clients, internal business functions and internal QA colleagues 
  • Effective developer of internal talent, succession-planning and career development of staff
  • Data-driven decision-making and management style
  • Solution-oriented
  • Excellent written and verbal communication
  • Geographic outsourcing experience 
  • 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

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:
  • Minimum of a Bachelor’s degree in a scientific discipline
  • 5+ years of management experience in a regional/global QA setting with decision-making authority or accountability regarding staffing, audit conduct, resolution of quality issues, regulatory interactions and budgetary responsibility 
  • Prior QA experience working in or with established bio-pharmaceutical companies or in in a services-based company
  • Reporting structure 
  • Reports to Global Head of QA; QA reports to the Chief Medical and Scientific Office, which is a corporate position.


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™.

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: R1041173