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Head of SQA and CSV, RDS IT - Director

Company: IQVIA Argentina
Location: Plymouth
Posted on: April 3, 2021

Job Description:

Primary Location: Durham, North Carolina, United States Additonal Locations: Plymouth Meeting, PA Full time R1185839 Date Posted: 03/19/2021 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:-- SQA & CSV Standards, Tools, and SDLC methodology:-- 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 evolution 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. Quality risk management and mitigations:-- 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.-- Periodic internal IT audits and inspections readiness:-- 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.-- Collaboration with Software engineering 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. 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.-- People management and leadership:
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.-- 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. --- B.S./M.S./MBA (or equivalent degree) and 12+ years of relevant work experience or relevant comparable background combined with at least 5+ years of management/supervisory experience.--
--- Broad and deep global health regulatory agency knowledge and experience interpreting and applying GxP requirements. Extensive experience in quality assurance, computer system validation/qualification, Software Development and/or Software Testing experience. Strong knowledge in CFR 21 Parts 11, GAMP5, IT controls methodologies, Annex 11 electronic record/electronic signature, and data integrity requirements, standards and guidelines. Strong background and understand of MHRA, FDA and other regulations. Working knowledge of software development lifecycle (SDLC) models.
--- Professional association membership and participation preferred, not required (e.g. RAPS, SQA (GCP/GLP), RQA etc.). Ideal candidate is expected to be well versed in GDPR, HIPAA and other patient privacy and safety relevant regulations. Ability drive privacy and security matter with legal, privacy and security functions are an added plus.
--- Knowledge and demonstrated experience in application of risk-based quality principles in a pharmaceutical environment. Proven ability to design/evolve and /or implement quality strategies and operational planning and oversight in a fit-for-purpose manner enabling effectiveness, flexibility and adaptability in a dynamic and evolving business model.
--- Demonstrated budgeting, strategic planning, execution, and project management skills required including working knowledge in validation practices of various computerized systems (configurable software, non-configurable software, off-the-shelf software).
--- Current knowledge of industry trends and best practices- for progressive quality risk management in a regulated environment including SQA functions, software testing, test automation and quality by design principals.--
--- Creative, innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness. Excellent communication skills and a proven track record of Influencing/building/promoting a culture of Quality and Excellence. Ability to multi-task and meet deadlines in a fast-paced environment.
--- Prior experience with agile software development processes, version control, configuration management, release management, and/or software quality assurance combined with experience in requirements decomposition and requirements a preferred Qualifications.
--- Knowledge of established Software Quality Standards - CMMI and/or ISO, specifically, experience working in organizations achieving and maintaining CMMI certifications.
--- Experience working in biotech/pharmaceutical, software product management or consulting/ services companies with relevant experience. 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 .
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 to arrange for such an accommodation.

Keywords: IQVIA Argentina, Plymouth , Head of SQA and CSV, RDS IT - Director, Executive , Plymouth, Massachusetts

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