Job Description

Process Compliance Lead



Primary Location: Wayne, Pennsylvania, United States Full time R1164657 Date Posted: 01/14/2021

Job description

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

Summary of Essential Job Functions
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
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 priorities
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

Supervisory Responsibilities
This position does not have supervisory responsibilities.

Minimum Experience Requirements
Requires 3-5 years of prior relevant experience
Bachelors in a Business or Technical field
Experience in process improvement techniques, facilitation, metrics, project management, and process mapping
Experience with Six Sigma / Lean
Experience with Pharmaceutical, Clinical Trial, and/or Financial Audit activities
Experience with SSAE18 SOC 1, SOC 2 and 21 CFR Part 11 preferred
Experience with Safe Harbor and Global Regulations preferred
Experience with managing or supporting internal and external audits
Skill Requirements
Highly motivated, team player energized by a fast-paced work environment that is effective in driving change management
Excellent collaboration and communication skills including presentation and listening skills with the ability to sell changes to key stakeholders and communicate the importance to operations
Strong leader skills: facilitation, collaboration, effective listening, situational awareness, conflict resolution, and emotional intelligence with the ability to influence others and drive change
Proven track record in handling multiple tasks and projects simultaneously, prioritizing workload effectively, and thriving in a dynamic and complex environment
Detailed oriented and strong business acumen
Outstanding problem resolution skills with an ability to look at solutions in unconventional ways to identify opportunities to innovate
Strong focus on quality, results and orientation towards accomplishing strategic organizational goals
Excellent project management, analytical and problem-solving skills
Ability to handle multiple, rapidly changing and sometimes conflicting priorities
Strong written and oral communication skills
Strong PC skills (i.e. Microsoft Office)
Ability to work independently in a global team environment to meet aggressive deadlines

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 IQVIAs Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.