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Quality Assurance Director (Clinical Research)

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Primary Location: Durham, North Carolina, United States Full time R1237317

Job description

Summary:

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 is a Director QA in the Customer Strategy team who will serve as the quality strategic engagement lead (SEL) for one or more key (i.e. accounts with established governance structures, account directors and multiple projects) IQVIA customers.  The SEL role includes the following activities for the assigned customers. The QA Director is responsible for serving as a strategic partner to external customers and internal project teams to drive GCP / Good Pharmacovigilance Practice (GVP) compliance and to , ensure that projects and deliverables are in compliance with regulatory requirements and industry best practices   This is a highly visible and key position within QA and requires both strategic vision and personal tactical execution. .

Summary of Responsibilities:

  • Collaborates with Quality counterparts at customers and with internal project teams to promote, support and facilitate proactive quality through the identification and management of risks and implementation of quality improvement activities.
  • Provides actionable insights from quality and operational data analysis and proactively works with the customer and the account team to develop action plans to drive continuous improvement. 
  • Analyzes trends in quality issue reporting and timeliness to ensure adherence to quality issue management requirements across project teams 
  • Supports the management and resolution of significant issues relating to quality.
  • In collaboration with Quality Management, ensures projects are inspection ready starting at the design stage.
  • Drives inspection readiness activities for the customer, including contributing to mock inspections by/of the customer
  • Contributes to the development of the global risk-based internal audit plan.
  • Advises customer Quality counterparts on the strategy for regulatory inspections and collaborates in the preparation for and management of inspections at customer offices and, as necessary, at investigator sites.
  • Prepares for and actively participates in relevant Governance/partnership level meetings e.g. Quality Councils/ Joint Operations Committee (JOC) or equivalent meetings with customer Quality counterparts.
  • Interfaces with senior management to discuss quality and compliance issues
  • Interfaces with business development and operations to identify business opportunities
  • May host and/or support customer audits and ensures appropriate and sustainable action plans are developed and implemented.


Required Knowledge, Skills, and abilities:

  • Thorough understanding of GCP, GVP (optional), and other relevant quality compliance requirements of major regulatory agencies (FDA, EMA, PMDA) and demonstrated experience interpreting and applying relevant regulations, laws, and guidance.
  • Practical experience applying proactive quality approaches for clinical trials.
  • Strong negotiation and influencing skills; demonstrated ability to work constructively and effectively at all levels across functions as well as with external customers 
  • Superb and polished ability to consistently present information in a clear, compelling, and understandable format, tailoring presentations to the context and audience.  
  • Demonstrable experience and ability to utilize analytics to make data-driven decisions and assess impact of interventions 
  • Ability to influence and guide others at all levels of management.
  • Possess applicable experience in conducting audits, writing audit reports and analyzing audits.
  • Demonstrated ability to lead and manage multiple responsibilities.
  • Ability to work independently as well as in a team environment.
  • Ability to coordinate timelines with internal customers and external vendors.
  • Ability to articulate and define departmental needs and processes.
  • Ability to establish and maintain effective working relationships with coworkers, managers

Required Education and Experience:

  • Bachelor’s 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 12 years of Quality Assurance experience in a Pharmaceutical, CRO, Biotech, Technical, and/or related area, including GCP.

#LI-Remote

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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

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.

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