QA\Regulatory Compliance Lead (R1117366) in Morrisville, NC at IQVIA™

Date Posted: 3/6/2020

Job Snapshot

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

• Lead definition of Features & Requirements relative to GxP, Privacy and Security Compliance Topics within IQVIA Vigilance build.
• Represent regulatory insights on GxP, Privacy and Security to IVP team technical development, practice development and support.
• Plan and Conduct interim compliance assessment to confirm at IVP Platform development meets compliance requirements
• Act a point of contact, provide instruction to individual Product Mgmt. and Engineering Development workstreams on methods, tools and work steps required to demonstrate IVP Compliance
• Define, Develop key metrics and actively report results about IVP Development and Testing/validation work products
• Assist with the Planning, Management and Performance of Product Level Testing/Accepted as assigned
• Conduct periodic review and assessment of IVP Activities and Deliverable to confer their suitability and availability for customer audit and/or regulatory inspection
• Perform or assist in the planning, scheduling, hosting and representation of IVP during Customer Audit and/or Regulatory Inspection
• Participate in the Product Mgmt. and Engineering Development Product Increment Planning events to ensure timely consideration of IVP capabilities and features required to meet health authority regulations
• Assist leaders from PV Tech Consulting Delivery and Managed Services Teams to design and implement the services, methods and tools required in their respective areas to fulfill health authority regulatory requirements.
• Prepare and deliver white papers and other thought leadership materials on the development, validation and customer deployment of Multitenant SaaS platforms for Safety Reporting.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

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.

Job ID: R1117366