IQVIA Process Compliance Lead in Bratislava, Slovakia
Join us on our exciting journey!
IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, Technology, analytics and human ingenuity to drive healthcare forward.
Overview: Process Compliance Lead
Plans, schedules, directs, controls, monitors, organizes, secures and manages resources to bring about the successful completion of programs and/or projects specific to a particular industry or specialty.
Sub Family Description
Develops and analyzes sustainable, repeatable, and quantifiable business processes and tools.
Monitors and troubleshoots process issues; completes root cause analysis to resolve process issues and identify system enhancements for improved processes and reporting; and liaises with Business Units to monitor and ensure the effective operation and utilization of integrated solutions by all employees.
Summary of Essential Job Functions:
The Process Compliance Lead is a key member of the Process Owner Network and is responsible for ensuring regional business needs are met, facilitating large process improvement projects which may include LEAN Sigma and Kaizen events, and analyzing complex business activities in order to make recommendations for improvement. In addition, is responsible for planning, conducting and documenting process compliance reviews on controls covering a broad range of processes to determine if functional areas are operating in accordance with established guidelines, policies, procedures, controls as well as governmental and legal requirements
Manage and coordinate process compliance reviews for Clinical Trial Payments
Publish process compliance report and present results to management
Analyze process compliance reports to determine process improvements, system enhancements or training needs and work with the Management and Training team do devise action plans
Identify and communicate suggested improvements to internal controls and procedures to reduce risk within the organization
Assist and participate in client audits for Clinical Trial Payments by coordinating external auditor requests, fielding questions from external auditors identifying potential audit issues, gathering relevant facts and data, communicating results to management
Manage and participate in SSAE18 SOC 1 Type II audits with external vendor to ensure compliance of established controls
Coordinate SSAE18 SOC 1 Type II audit activities and deliverables
Assist with Corrective and Preventive Actions (CAPAs) and incident reports for the Payments organization
Provide guidance and support with remediation activities
Support project teams during quality-related sponsor meetings and calls
Assist with vendor assessment and qualification questionnaires
Identifies and screens process improvement opportunities/projects, which may include LEAN Sigma & KAIZEN Events
Support continuous improvement activities by ensuring process and technology enhancements are in line with internal and audit controls
Collaborate with regional stakeholders to ensure process improvements are in line with business needs and priorities
Facilitates sessions with users, subject matter experts, and/or business owners to extract key user and business requirements and priorties
Develop and manage end to end project plans inclusive of milestones and launch schedule to ensure successful delivery of process improvement initiatives
Monitors and communicates project progress to the team, colleagues and management
Maintains project plan / process map documentation to reflect changes in the operating procedures
Collaborates with the Global Training Team to ensure SOPs, documentation and training programs are updated according to any process changes
Serves as a liaison between clients or users and developers to ensure that business requirements are effectively translated into technical specifications
Gathers and monitors key metrics to assess project performance
Presents complex processes in a manner that can be understood by all business audiences
Other duties as assigned
Our Ideal Candidate Will Have:
Bachelors degree in Business or Technical Field or relevant experience
Typically requires 3 - 5 years of prior relevant experience.
Experience in process improvement techniques, facilitation, metrics, project management, and process mapping
Experience with Pharmaceutical, Clinical Trial, and/or Financial Audit activities;
Experience with Six Sigma / Lean
Experience with Safe Harbor and Global Regulations preferred
Experience with SSAE18 SOC 1, SOC 2 and 21 CFR Part 11 preferred;
Experience with managing or supporting internal and external audits
We know that meaningful results require not only the right approach but also the right people . Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and
Whatever your career goals, we are here to ensure you get there!
We invite you to join IQVIA™.
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 a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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