QA Director

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 QA Director is to oversee and coordinate assigned quality assurance programs in support of customer accounts, functional accounts, audit and inspection programs or the QA quality management system. Key aspects of this tole include the generation and provision of insights and analyses that support in the assessment and promotion of compliance with regulations, guidelines, operating procedures, risk identification and mitigation and quality improvement initiatives.

Summary of Responsibilities:

• Establish and maintain strong working relationships with internal business partners and counterparts, as assigned
•  Provide actionable insights to internal business counterparts, QA Leadership and Senior Management to drive quality improvements and efficiencies, and risk mitigation based on QA data analyses coupled with operational performance data and knowledge of process management, changing regulations and customer expectations.
• Provide consultation and support concerning compliance with regulations appropriate controls, quality measures and risk assessment and mitigation in the development of improved or new service offerings across the business.
• Lead and project manage internal QA quality improvement initiatives
•  Assist in enhancement of quality assurance and control policy, and risk identification and mitigation by providing consultation and recommendations to regional and Global QA Leadership.
• Serve as author for QA SOPs and/or reviewer of procedures/processes for other IQVIA functional areas as assigned.
•  Participate in or lead teams for special projects as assigned. Teams may be cross functional.
• Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.
• Support customer audits and/or regulatory inspections, as required.
• Recommend process and systems for audit, review process and systems audit plans and oversee the delivery of these audits, review the CAPAs and ensure appropriate follow up.
• Oversee documentation, reporting, and closure of significant compliance issues.
• Support QA Leadership in proposal reviews and reporting QA metrics and insights. Act as primary back-up for QA Leadership.
• Present trend analysis results and QA metrics and insights to senior management.
•  Ensure proper coordination of customer-initiated audits and mock regulatory inspections and manage regulatory facility inspections.

Required Knowledge, Skills and abilities:

• Thorough understanding of GCP, PV, and other relevant quality compliance requirements of major regulatory agencies (FDA, EMA, PMDA, MHRA, TGA, etc.) 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 
• Knowledge of the pharmaceutical research and development process, clinical research and the regulatory environment.
• Considerable knowledge of quality assurance processes and procedures.
• Excellent interpersonal, problem solving, risk analysis and negotiation skills
• Effective organization, communication, and team orientation skills.
• Ability to influence and guide others at all levels of management.
• Demonstrated ability to lead and manage multiple responsibilities.
•  Ability to work independently as well as in a team environment.
•  Ability to work independently as well as in a team environment.

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 10 years of experience in experience in clinical quality in a pharmaceutical, biotech, or other regulated industry. 

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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.