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Global Head, CSV and Quality Management External Technology

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Primary Location: Durham, North Carolina, United States Full time R1230204

Job description

Job Overview:
Exciting opportunity to be accountable for the strategic leadership and oversight of R&DS External Technology end to end Quality Management System (QMS) and Computer Systems Validation (CSV) function globally. The role serves as the lead for driving the quality and compliance requirements for this business unit and will be the lead interface working with the technical and quality stakeholders across the business. It will also interface with security, privacy and legal offices as required. The role will be responsible for partnering with the product, delivery and engineering teams to develop the minimum regulatory requirements as within our SDLC and project lifecycles including CSV, Risk Management, data privacy as defined by ICH and GxP requirements.

Key Responsibilities:

  • Quality risk management and mitigations:

Provides strategic direction and oversight to development, execution, and continual improvement of quality risk management/mitigation strategies for all External Technology program area as well as partner with the broader IQVIA tech organization to resolve applicable issues and concerns including coordination with IQVIA’s privacy, legal and security office for such privacy and security issues. Provide alignment and oversight to the Implementation of risk-based approaches to quality for technology and service delivery programs e.g. Quality by Design principles, risk-based quality management (RBQM) and ensures effectiveness of mechanisms for ongoing quality risk monitoring, mitigation, and management. Track the effectiveness of corrective & preventative actions (CAPA) developed by product teams and ensure the adequate and timely implementation of CAPA commitments.   Support study and project level activities across the service delivery organizations within external technology.

  • QMS, CSV Standards and SDLC /Project Lifecycle methodology:

Own, manage, evolve, the external technology Quality Management System, as well as contribute to the CSV,SDLC and project lifecycle methodology. Align SOPs, work instructions including tools /process implementation and training/change management across the External Tech teams.

  • Collaboration with Software engineering and study/project delivery teams:

Collaborate with software engineering team leaders and members to leverage technical experience and depth to help bring more automation and efficiency to the development process, contributing to DevOps , agile,  CICD pipeline for higher frequency, high quality software releases. Provide timely, accurate updates to executive management. Incumbent is also responsible to provide strategic guidance on all performance, scalability and non-functional requirement (NFR), establishing and ensure adherence to quality by design principal including privacy matters.   

Contribute to delivering improved study level project lifecycle across the service delivery organizations.  

  • People management and leadership:

Lead a high performing and expert team of Quality Management professionals in accordance with organization’s policies and applicable legislation to deliver on business outcomes for RDS External tech. Responsibilities include planning, assigning, departmental goal settings, and directing work, appraising performance, and guiding professional development. Approve actions on human resources matters, including salary administration.

  • Periodic internal audits and inspections readiness:

Perform periodic audits and inspections of all RDS Technology area in accordance with internal QMS and CSV functions to ensure compliance. The incumbent is also responsible to coordinate all audits and inspections activities for the organization in accordance with relevant IQVIA stakeholders or internal /external inspectors, business stakeholders as applicable to support quality outcomes and real time inspection readiness.

  • Quality metrics, measurement, and reporting:

Develop, implement, and maintain set of KPIs across RDS IT to perform quality assessments and analyses, gain insights into program and systematic /procedural risks , issues, drive continuous improvements initiatives,  and proactively communicate to relevant stakeholders including KPI reporting to senior management. Provides leadership coordination and direction to benchmarking with external peers and industry for establishing QA operational performance

targets/goals in support of excellence, value, and, impact. Proactively research and communicate industry and global quality trends and initiatives to ensure compliance and to identify continuous process improvement opportunities.

  • Departmental Budget, resources, software products, and financial management:

Develop SQA and CSV departmental budget, estimate SQA and CSV estimate for IT programs and deliver according to project timeline and allocated budget. Lead quality program activities for assigned products – including but not limited to product quality reviews, risk reviews, SDLC/process consulting, and audit support. Oversee the tracking of quality programs. Software products, and releases/projects with respect to milestones, deliverables, and quality of demonstrated results.

Qualifications:
• Bachelor's Degree Life sciences or equivalent nursing qualification Req
• 12 years experience in Clinical Monitoring, including at least 2 years experience in a role equivalent to a Clinical Project Manager/Clinical Team Lead, preferably within IQVIA. Equivalent combination of education, training, and experience. 4 years experience in Quality Management or Quality Assurance.
• Sound working knowledge of medical terminology, standard operating procedures (SOPs), Good Clinical Practice (GCP), Food & Drug Administration (FDA) regulations, quality improvement initiatives, and processes.
• Knowledge of National and International Regulations and Drug Development process.
• Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.
• Knowledge of IQVIA corporate standards and SOPs.
• Excellent organizational, interpersonal and communication skills.
• Excellent judgment and decision-making skills.
• Excellent leadership and line management skills.
• Excellent influencing and negotiation skills.
• Strong computer skills including Microsoft Office and Clinical Management applications.
• Excellent problem solving skills.
• Excellent ability to work in a matrix environment.
• Excellent ability to lead and motivate a clinical team also required.
• Ability to travel extensively globally/ within the region.
• Excellent ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Fluent in English.

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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