Director of IT Systems, FDA Compliance and QA

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San Diego, CA

The Director of IT Compliance and Quality Assurance will lead the planning, development, and support of the Compliance and Quality Assurance environments, methodology, tools, and resources. Key Responsibilities: * Develop teams of professionals that drive quality initiatives to successful completion * Develop and support strategies for quality assurance and validation * Produce a long term strategy for test automation * Manage the delivery of software quality services in a large, complex environment * Oversee all Validation activities * Collaborate with external QA resources to ensure complian (more) The Director of IT Compliance and Quality Assurance will lead the planning, development, and support of the Compliance and Quality Assurance environments, methodology, tools, and resources. Key Responsibilities: * Develop teams of professionals that drive quality initiatives to successful completion * Develop and support strategies for quality assurance and validation * Produce a long term strategy for test automation * Manage the delivery of software quality services in a large, complex environment * Oversee all Validation activities * Collaborate with external QA resources to ensure compliance * Collaborate with Applications Development, Infrastructure, and other internal and external teams for quality related items * Ensure compliance with document controls and records * Participate in ongoing process improvement activities * Provide direction to create solid lean methodology which will ensure quality deliverables * Oversee global compliance within Information Technology * Budget, plan, and control operating costs, capital project costs, and other expenses * Mentor and develop team members to become the top caliber in the industry * Responsible for hiring, performance assessment, and staff retention The minimum requirements to qualify for this position are as follows: * Experience managing teams testing IT applications and systems, ideally SAP or ERP related in a regulated environment * MBA or MS degree in Information Technology or equivalent education and work experience * Minimum of 7 years of experience in FDA validation and compliance with at least 5 years of senior management experience *SAP Quality Center experience or Mercury Toolset experience Qualifications also include (items are required unless noted otherwise): * Ability to influence and effectively communicate across all levels of the organization * Strong project planning and management capabilities * Extensive knowledge of and hands-on experience with formal QA methodologies, tools, and techniques * Experience in performing the full range of test execution activities, including developer / unit, functional, performance / load / capacity, regression, integration, and user acceptance testing * Hands-on experience in planning, developing, executing, and validating major QA efforts on complex projects * Strong interpersonal, oral and written communications skills * Solid technical skills and background to support the oversight of development and management of complex multi-platform testing environments * Strong project management, customer service, and conflict management skills that can be applied in providing support and direction to team members and key business and IS staff leading projects * Proven ability to develop and implement initiatives successfully from the strategic planning phase through execution and post-implementation * Proven ability to build and manage senior level QA team members and partner with IS and business area representatives in leading and supporting QA activities * Solid background in applications development methodologies, SDLC, and other IT industry standards * Experience in the Healthcare Industry is preferred (less)

source: seeker.dice.com

11 Mar 2010