(ITLS) Validation Lead / Validation Manager
Quintiles Transnational - United States

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Why Quintiles? A career at Quintiles puts you at the corporate center of the leading worldwide pharmaceutical services organization. We been named to the 2008, 2009 and 2011 lists of Computerworld's "100 Best Places to Work in IT" . Quintiles IT was also listed as the leading company for the pharmaceutical industry on the 2011 "InformationWeek 500" and ranked within the top five overall!

If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. We are seeking dynamic, highly motivated and results focused individuals that take an innovative and consultative approach to driving and achieving success. Apply now for our Validation Lead / Validation Manager, Life Cycle Safety position located in our Morrisville (Raleigh/Durham), NC office.

The Validation Lead / Validation Manager will lead and drive global teams to build and execute effective testing strategies, leading to a successful delivery of products built on Quintiles' Lifecycle Safety Program built on Oracle's Argus safety platform.

RESPONSIBILITIES

  • Lead/manage, multiple ongoing Software Validation and Testing (SVT) projects in the Lifecycle Safety program domain and Oracle's Argus product.
  • Execute on departmental initiatives to grow and incrementally mature Quintiles' testing and quality management capabilities.
  • Provide technical and regulatory guidance to Test Managers, Test Leads and their teams on day-to-day basis.
  • Lead / facilitate development of sound risk based test strategies and plans that provide adequate consideration to business and technical drivers.
  • Develop / review SOP's, Master Validation Plan, Traceability Matrix, Testing deliverables, and Data Migration Plans.
  • Manage matrixed execution of the test strategy across functions in Quintiles IT and business units. In particular be effective in working with business analysis, development, operations and product management teams.
  • Ensure adherence to internal testing best practices/standards.
  • Execute effort to ensure consistent approach to how teams document and communicate results.
  • Coordinate with the test managers to report staff utilization and the testing status (highlighting business value delivered) to project & program managers on a regular basis.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
  • Minimum of 4 years work experience in software validation in a highly regulated environment.
  • Drug Safety domain and experience in the implementation of drug safety system projects will be preferred.
  • Experience working effectively in globally diverse teams and matrixed organizations.
  • Experience working with global testing teams on large product implementations in the Drug Safety domain.
  • Excellent Understanding of 21 CFR Part 11 and GxP Regulations.
  • Strong Understanding of GAMP Guidance and Principles.
  • Ability to see the big picture of a product (quality and testability) and yet be able to narrow down in specific areas to build a testing approach or resolve issues.
  • Must have strong knowledge in various life cycle methodologies, including Lean and Agile software development.
  • Customer service orientation
  • Driven by passion for enabling high performance from teams with the goal of high quality delivery.
  • Proven experience in risk management and product delivery experience in a regulated environment.
  • Proactively initiate, develop and maintain effective working relationships with team members.
  • Work well with others through cooperation and negotiation
  • Results oriented
  • Strong teambuilding skills
  • Accountability
MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree in computer science/engineering highly preferred. ( must have proven technical knowledge and experience accompanied by strong leadership capabilities).
  • Solid understanding of Lifecycle Safety/ Drug Safety domain and experience in the delivery of testing engagements on medium to large projects in this domain. Experience in the delivery of Drug Safety projects using Oracle's Argus product will be preferred.
  • 4-6 years of software development life cycle quality management, quality assurance, of which at least 2 years should have been in a leadership role
  • Experience working within an on-shore/off-shore systems development and support environment preferred.
  • Ability to build strong relationships in a multi-cultural environment across all levels within IT.

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