ITLS Associate Director Director IT Validation and Testing LifeCycle Safety Job
Research Triangle Park,
Job Code - 1204524
Position - FULL TIME
Job First Active on: Tuesday, March 20, 2012
(ITLS) Associate Director Director, IT Validation and Testing, LifeCycle Safety
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 Associate Director/Director, IT Validation and Testing, Life Cycle Safety position located in our Morrisville (Raleigh/Durham), NC office.
The Associate Director, IT (AD, IT) 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. The AD-IT will lead all aspects of testing through all stages of the system development lifecycle including the creation, deployment and continuous improvement of best practices.
· Build, grow and incrementally mature Quintiles' testing and quality management capabilities in the Lifecycle Safety program domain and Oracle's Argus product.
· Lead the testing and quality management activities across the SDLC.
· Provide leadership and technical guidance to Test Managers, Test Leads and their teams.
· Responsible for driving efficiency, agility and effectiveness in the end- to-end testing process.
· Lead, facilitate and enable teams to develop test strategies and plans that provide adequate consideration to business and technical drivers and associated risks.
· Creating and reviewing SOP's, Master Validation Plan, Traceability Matrix, Testing deliverables, and Data Migration Plans.
· Drive 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.
· Assess and track people availability and utilization to deliver against the agreed test plan and within the applicable schedule and budget constraints.
· Ensure adherence to internal testing best practices/standards.
· Oversee effort to drive in-process root-cause analysis (RCA) along with corrective & preventive action (CAPA) to ensure that problems are resolved.
· Oversee effort to ensure consistent approach to how teams document and communicate results.
· Analyze test results and measure/report KPI's against defined quality criteria for products.
· Provide oversight across projects to ensure that test deliverables including the use of tools are completed per expected internal guidelines.
· Collaborates with peers in other teams to understand dependencies and effectively mitigate risks and issues.
· Participate in the product budgeting/estimation process, working to make sure appropriate budget/resource levels are being maintained to deliver work required
· 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.
· Support and foster an environment conducive to innovation, high productivity, and high quality.
REQUIREMENTS - QUALIFICATIONS: (ITLS) Associate Director Director, IT Validation and Testing, LifeCycle Safety
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
· Minimum of 2 years work experience in the Pharmacovigilance, Drug Safety domain and experience in the implementation of drug safety system projects will be prefered.
· Experience working effectively in globally diverse teams and matrixed organizations.
· Experience in leading and mentoring global testing teams on large product implementations in the Drug Safety domain.
· Excellent Understanding of 21 CFR Part 11 and GxP Regulations.
· 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.
· Experience of planning and executing testing engagements in the cloud will be useful, but not mandatory.
· Customer service orientation
· Driven by passion for enabling high performance from teams with the goal of high quality delivery.
· Previous program and project management experience will be preferred.
· 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
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
· MS or an MBA with a specialization in Information Systems or Bachelor's degree highly preferred. ( must have proven technical knowledge and experience accompanied by strong leadership capabilities).
· Quality and/or testing certification such Lean Six Sigma, CSQE, PMP certification will be useful but not mandatory.
· 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.
· 6-8 years of software development life cycle quality management, quality assurance, of which at least 4 years should have been in a leadership role
· Ability to accelerate delivery through the optimization of processes and ongoing introduction of efficiencies. Experience in the implementation of business process re-engineering practices will be helpful.
· Experience working within an on-shore/off-shore systems development and support environment.
· Ability to build strong relationships in a multi-cultural environment across all levels within IT.
· Proven ability to make those around you better, including everyone from individual contributors up to senior management. Proven technical knowledge that will enable the AD-IT to effectively work with the team.
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