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VP, Quality Assurance(Clinical Research)

Aplica ya
Mapa de ubicación: Durham, North Carolina, United States Full time R1315000

Descripción del trabajo

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:

Accountable for driving a culture of quality and compliance by setting clear team deliverables which are connected to business unit strategy and leadership of teams. Provide advice, support, and consultancy widely across the business to promote a culture of quality and compliance. Accountable for implementation of efficient and effective process delivery controls to enable IQVIA to operate at the cutting edge of quality in the industry. Support the SVP of Enterprise Quality Assurance in identifying new opportunities and new directions to enhance quality of delivery across the business.

Responsibilities:

  • Approves and implements a QA strategy in conjunction with the SVP of Enterprise Quality Assurance Accountable to direct QA programs of work to ensure IQVIA procedures, services and facilities operate to the highest level of compliance and reliability. Drive QA delivery program in support of customer & functional accounts, audit and inspection programs, business analytics and QA quality management system. 
  • Deliver an effective and targeted audit & CAPA programme, and investigate and resolve quality and compliance issues while providing actionable insights that prevent recurrence of root causes
  • Enhance the capabilities of the QA function operationally through effective QMS orchestration and through tech-enabled innovation to support strategic areas to deliver high growth
  • Ensure teams have clear focus and understanding of strategy and that services are executed to the highest standards within budget.
  • Supports, fosters, directs, and implements appropriate cultural component quality standards and metrics across the business
  • Identifies areas of regulatory and delivery risk, and brings these to the attention of Senior management, as appropriate
  • Works with Quality Management and operational staff to produce and implement remedial action plans
  • Works with the SVP of Enterprise Quality Assurance, and senior management to define and implement a Core Quality Standards worldwide.  Works with unit QA staff to identify and drive areas for process improvement (PI), selects those processes where PI techniques would have a high likelihood of success, and then selects and implements an appropriate PI technique for each process
  • Participate in or lead teams for special projects as assigned. Teams may be cross functional

Required Knowledge, Skills and Abilities:

  • Requires advanced business knowledge, general management, and leadership capability to lead business or functional teams.  Global experience required; experience with JAPAC highly preferred.
  • Extensive experience in regulated environments – Good Clinical Practice, Good Pharmacovigilance Practice, Good Laboratory Practices.
  • Experience with Regulatory Authority Inspections
  • A leader with extensive team player capabilities
  • Possess working knowledge of ISO, Quality Management (QM) principles and Process Improvement (PI) techniques, and laboratory accreditation requirements as required for the assigned business line.
  • Experience of Budget Management
  • Possess excellent written and verbal communication skills
  • Possess a diplomatic, understanding approach to the conduct of audits
  • Possess current awareness of industry trends and regulatory authority opinion.
  • Possess strong organizational skills.
  • Demonstrates an active interest/participation in industry/professional activities.
  • Ability to work within a global team. Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Required Education and Experience:

  • Bachelor's Degree (Advanced Degree preferred)
  • 10+ years’ experience in a highly regulated environment (FDA,, EMA. ISO), with experience solving tactical problems within a specialized field. Equivalent combination of education, training, and experience.
  • Demonstrated experience operating across Clinical and Real-World Studies (Ph I-IV)
  • Demonstrated experience leading and successfully and timely delivering on implementation of cross-functional initiatives and programs with senior executive leadership visibility.
  • Demonstrated expertise in implementing a quantitative approach to quality risk management.
  • Minimum 10 years of experience in industry, with at least 5 years of experience in pharmaceutical, biotech, or other regulated industry with a focus on enterprise risk management activities

#LI-Remote

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

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