Associate Director, IT Quality Engineer

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Foster City, CA
Job Type
Direct Hire
Feb 28, 2018
Job ID
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Associate Director, IT QE is a validation/SQA professional leading and accountable for the validation of systems supporting the (1) G&A vertical, and (2) R&D and PDM IT vertical, through subordinate managers, staff, and managed services. 

Job Description

  • Develops all resource and manpower plans for the area.
  • Manages activities of the group(s), coordinating/integrating across project boundaries as appropriate.
  • Ensures individual goal setting is effectively linked to corporate and department goals.
  • Ensures resources and organization structure are in place and operating effectively.
  • Develops draft budgets and manages approved budget for the group(s).
  • Addresses organizational challenges by helping staff navigate the organization effectively and resolving the diverse perspectives of stakeholders.
  • Addresses unusual and non-recurring problems by devising approaches to assess the situation, evaluating options, and introducing new procedures or tools, as necessary.
  • Proactively makes recommendations to appropriate business units regarding the development of new services, projects and goals that further support and strengthen the capabilities of the business unit.
  • Seeks out and plans technical direction for the group(s).
  • Directs testing and validation activities on multiple projects, usually through subordinate project managers.
  • Develops and/or ensures the development of accurate and thorough forecasts.
  • Communicates with others across technologies, platforms, systems, etc.
  • Manages business partner expectations on which projects may be funded and resourced.
  • Contributes to the identification of funding sources for priority projects.
  • Anticipates conflicting needs and proactively resolving them.
  • Supports the project team to ensure success, including removing roadblocks, helping the team to navigate the organization, etc.
  • Integrates resources effectively, including resources under the direct control, or controlled by contractors, vendors, etc.
  • Ensures that projects are on time, on budget and meet the needs of the business.
  • Identifies when additional funding is needed based on scope changes.
  • Interacts extensively with business partners to provide technology solutions; develops relationships with business partners and staff to develop solutions.
  • Fosters excellent cross-functional communications and integrates the work of managers to achieve business objectives.
  • Develops broad and productive networks with internal and external business partners.
  • Enables the assessment and evaluation of new technologies by bringing together key parties (e.g. internal/external resources, clients).
  • Seen as a resource by business management for information about emerging/specialty technologies.
  • Communicates key company strategies and objectives to the group(s) in a clear and timely manner.
  • Maintains and updates existing documentation and standard operating.
  • Works with technology professionals and managers to develop technology solutions that meet clients’ requirements.
  • Contributes to various analyses (for example, organizational, systems, feasibility, cost/benefit studies, implementation plans).
  • Oversees the implementation of technology solutions.
  • Continually improves work procedures and processes for group(s) managed.
 Essential Duties and Job Functions:
  • Developing and documenting User, Functional and Design requirements; Installation, Operational and Performance Qualification protocols and reports; Standard Operating Procedures; requirements traceability; Infrastructure Qualification and change control.
  • Leading and managing people who perform qualification/validation activities in accordance with requirements, master plans, procedures and protocols.
  • Providing training and support to IT staff on change control, issues and audit preparation.
  • Collaborate with regulatory specialists in Legal, Quality and Compliance to develop IT methodology to implement compliance in an efficient manner.
  • Providing support for systems used in drug development, manufacturing, quality control and quality assurance.
  • Ability to assist with design considerations for more complex projects that may involve multiple technical teams.
  • Participates in the identification of risks and the development of mitigation strategies for projects.
  • Supports project teams to provide assurance that requirements, design, and other project deliverables meet standards as appropriate.
  • Drives test execution and status reporting.
  • Manages and monitors defect reports and works with developers and other project team members to verify resolution.
  • Supervises and mentors staff.
 Knowledge, Experience and Skills:
  • Typical candidates will possess 10+ years of relevant experience and BA/BS Degree, or equivalent OR 8+ years with advanced degree or equivalent.
  • Has a strong working knowledge of the testing process, designing test scenarios and test scripts, including of understanding of various software quality practices, with the ability to learn and apply new and emerging concepts very quickly.
  • Has developed a broad understanding of the interoperability of systems and technologies to the testing/validation effort.
  • Seen as a technical resource in the testing and validation team on testing tools and methods.
  • Has experience with structuring the testing tasks on multiple projects, estimating schedules, resources and dependencies.
  • Demonstrates an expert understanding of all relevant application development processes including the project management methodology, serving as a resource to others.
  • Has experience applying automated testing tools.
  • Serves as a resource to project team on regulations related to testing and documenting automated systems.
  • Demonstrated breadth and depth in information technology and/or pharmaceutical industry experience with exposure to a broad range of GxP validation activities such as document control, computer systems, vendor assessment, and change control.
  • Demonstrated breadth and depth experience performing testing and system validation work in a GxP environment.
  • Must possess excellent technical writing, documentation and communication skills.
  • Experience with managing a validation team of onshore/offshore service providers.
  • Knowledge of FDA requirements for computerized systems, including experience interpreting 21 CFR Part 11 and EU GMP Annex 11 requirements.
  • Knowledge and experience with the GAMP approach to computer system validation lifecycle management
    Strong attention to detail, quality oriented.
  • Seen as a technical resource in the testing and validation team on testing tools and methods.
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