Head of SQA and CSV, RDS IT Job Overview:
Accountable for strategic leadership and overseeing of R&DS IT’s end to end Software Quality assurance (SQA) and Computer systems validation (CSV) function globally. The role serves as the primary interface for internal and/or external audits and inspections including but not limited to coordination with applicable authorities, IQVIA’s security, privacy, or legal offices. The key responsibilities include:
Own, manage, evolve, and enforce RDS IT SQA tools, standards, and methodologies, identify and implement improvement opportunities, establish, measure and report on appropriate KPI for the department. The incumbent is also responsible for the volution and agile transformation of RDS IT SDLC, SOPs, work instructions including tools /process implementation and training/change management. This also includes overseeing the certification and recertification process of CMMI Maturity Levels.
Provides strategic direction and oversight to development, execution, and continual improvement of quality risk management/mitigation strategies for all RDS IT 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 oversight to the Implementation of risk-based approaches to quality for IT 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.
Perform periodic audits and inspections of all RDS IT program area in accordance with internal SQA 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.
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.
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.
Lead team of SQA and CSV professionals in accordance with organization’s policies and applicable legislation to deliver on business outcomes for RDS IT. 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.
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.
Ideal candidate:
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.
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