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Manager of Quality Assurance (R1071198) in Wayne, PA at IQVIA™

Date Posted: 5/19/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Wayne, PA
  • Experience:
    Not Specified
  • Date Posted:
    5/19/2019
  • Job ID:
    R1071198

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 Manager of Quality Assurance is primarily responsible for ensuring quality and compliance by contributing information and analysis of the business operations processes, implementing production, productivity, quality and standards; ensuring compliance with controls and operating procedures; completing and managing audits; and proposing process and system improvements. The Manager of Quality Assurance will ensure that all documentation and processes meets company, financial, and SSAE18 (SOC 1 Type II) standards.  


Summary of Essential Job Functions 

  • Manage and coordinate internal and client audits for the payment’s organization 
  • Responsible for reviewing and publishing internal audit report to management 
  • Responsible for analyzing internal and external audit reports to determine process improvements, system enhancements or training needs and working with the Management, Product and Training team do devise action plans
  • Manage and participate in SSAE18 SOC 1 Type II audits
  • Provide Quality Management support during SDLC activities. Participate as needed in scrum meetings and development planning. 
  • Author Corrective and Preventive Actions (CAPAs) and incident reports for the payments organization  
  • 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
  • Interface with the Product Team to ensure that the Global Quality Management System (QMS) Policies, System Development Life Cycle and the business unit SOPs are followed. 
  • 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.
  • Review and approve SOPs, Work Instructions, process maps, client communications associated with any compliance, audit or quality questionnaires and validation deliverables 
  • Review and approve SDLC deliverable's including requirements, test protocols, GXP assessments, defect reporting, plans and reports by partnering with key stakeholders. 
  • Perform system and process Risk Assessments in conjunction with the business. 
  • Ensure requirements and processes comply with company global quality Management System policies and SOC 1 and SOC2 controls. 
  • Building strong relationships with internal and external clients providing strategic support and driving client satisfaction with the quality management and quality over site
  • Manage and support project teams during quality related sponsor meetings and calls 
  • Manage and train members of the Quality Management team and designees 
  • Manage and coordinate vendor assessment and qualification questionnaires 
  • Monitor and support continuous improvement activities
  • Provide guidance and support with remediation activities
  • Other duties as assigned

Supervisory Responsibilities

This position has responsibility for managing Quality Management team members 


Minimum Experience Requirements

  • Bachelor’s Degree in science/business or at a minimum 7 years of Quality Assurance/Validation experience in a regulated industry  
  • Knowledge and experience of Agile SDLC and system validation 
  • 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

- Participation in audit and vendor assessment activities

  • Experience with SSAE18, SOC 1, SOC 2 and 21 CFR Part 11
  • Experience with Safe Harbor and Global Regulations 
  • Experience with managing and supporting internal and external audits 
     


Skill Requirements    

  • Ability to organize and present information in clear and concise formats
  • Strong focus on quality, results and orientation towards accomplishing strategic organizational goals 
  • Excellent project management, analytical and problem-solving skills
  • Exceptional collaboration and listening skills required 
  • Ability to quickly learn new concepts and tools is necessary
  • 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

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™

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 workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1071198