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Business Analyst (R1038785) in Wayne, PA at IQVIA™

Date Posted: 12/7/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Wayne, PA
  • Experience:
    Not Specified
  • Date Posted:
    12/7/2018
  • Job ID:
    R1038785

Job Description

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.

About DrugDev, An IQVIA Company
DrugDev is committed to providing sponsors, CROs and sites with solutions that transform clinical research through collaboration, standardization and an outstanding technology experience. We are proud to provide a unified clinical operations suite that enables most top pharma and CROs to use technology enabled solutions to accelerate clinical operations

Job Summary

The Quality Analyst is primarily responsible for ensuring quality and compliance by providing support and guidance at an innovative clinical trials and financial services company.

The Quality Analyst will ensure that all documentation meets company, financial, and SSAE 16 standards.  The Quality Analyst will interface with the development team and the Business Analysts to ensure that the Global Quality Management System (QMS) Policies, System Development Life Cycle and the business unit SOPs are followed.

The Quality Analyst will also review and approve business unit process maps, SOPs, Work Instructions, client communications, validation deliverables, and participate in project management. The Quality Analyst will perform system and process Risk Assessments in conjunction with the business.

  •  Summary of Essential Job Functions

  • Review and approve SOPs, Work Instructions, SDLC deliverables including requirements, test protocols, defect reporting, plans and reports by partnering with key stakeholders.
  • Approval of end-to-end testing activities including reviewing development, testing, defect reporting and closure, and summary reports to ensure objectives and compliance requirements are met.
  • Author planning, gap assessment, requirements and other SDLC documents as needed by partnering with key stakeholders to ensure defined business needs are met and in accordance with Quality Standards
  • Provide Quality Management support during SDLC activities. Participate as needed in scrum meetings and development planning.
  • Ensure requirements and processes comply with company global quality Management System policies and SOC 1 and SOC2 controls.
  • Support and coordinate internal and client audits for the payments organization
  • Provide guidance and support with remediation activities.
  • Author Corrective and Preventive Actions (CAPAs) for the payments organization  
  • Monitor and support Continuous Improvement Activities
  • Other duties as assigned

Supervisory Responsibilities

This position does not have supervisory responsibilities

Minimum Experience Requirements

  • Bachelor’s Degree in IT, Business, Accounting, Finance or related area
  • Strong knowledge of software testing and SDLC processes
  • Experience with Pharmaceutical, Clinical Trial, and/or Financial Software Quality Management activities including:
    • reviewing and approving quality deliverables of the SDLC process including user requirements, risk assessment, testing protocols
    • reviewing and approving SOPs, Work Instructions.
    • JIRA or other Agile Scrum management system
    • coaching team members on quality policies and practices
  • 3-5 years working in quality assurance/management in a regulated industry.  SSAE16 or 21 CFR Part 11 experience is preferred.
  • Previous quality process training experience is preferred.
  • Previous participation in audits is preferred.

Skill Requirements

  • Confident organized and detail oriented self-starter
  • Ability to organize and present information in clear and concise formats
  • Excellent problem-solving skills
  • Exceptional collaboration and listening skills required
  • Ability to quickly learn new concepts and tools is necessary
  • Strong written and oral communication skills
  • Ability to work independently in a global team environment to meet aggressive deadlines

Awards

  • FORTUNE Magazine's World's Most Admired Companies list for the third year in a row.
  • Recognised by the 2016 Scrip Awards as the Best Full-service Provider Contract Research Organization (CRO).
  • Awarded the 2016 Eagle Award from the Society for Clinical Research Sites (SCRS) for the fourth consecutive year. A site-nominated award recognising contract research organizations (CRO) and biopharmaceutical sponsors dedicated to building positive relationships with research sites through leadership, professionalism and integrity.
  • IQVIA™ named in The International Association of Outsourcing Professionals (IAOP) 2017 Global Outsourcing 100® List which recognizes the world’s best service providers across a range of industries.

We value the well-being of our team members and offer a comprehensive suite of benefits. These include Medical, Dental, Vision, Flexible/Health Savings’ accounts, Life and Disability, 401(k) with employer match, generous paid time off and flexible work schedules in a fun, business casual environment.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled'

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 ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1038785