Director, IT Quality Assurance

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Location
Bay Area, CA
Salary
$200,000 - $225,000
Job Type
Direct Hire
Date
Nov 08, 2018
Job ID
2613405
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The Director, IT Quality Assurance is responsible for the strategy, planning and execution of the IT Quality Management System ( IT QMS) and leads a team of IT Quality Assurance and operations professionals. This role provides thought leadership that will help to mature our Quality Assurance Management, and Quality Engineering practices.STATUS: Full Time


ATTRIBUTES
  • Bachelor’s Degree required; degree focused in Computer Science, Software Engineering, Life Sciences or Business Administration preferred.
  • 12 to 15 years of Quality & Compliance experience required; experience with hands-on computer system validation and IT infrastructure qualification preferred.
  • Knowledge in FDA  and EU regulations, cGxP, cGMP, cGLP, ISO 9001, Systems Development Lifecycle (SDLC), Change Control,  Policy and SOP Development, SQA Methodologies, and GAMP 5.
  •         Excellent written and verbal communication skills.  Ability to partner with and influence a diverse group of stakeholders inside and outside of Information Technology.
RESPONSIBILITIES
  • Leadership. Provide leadership and vision to a team of IT Quality Assurance professionals who support global IT quality assurance and compliance. Hire, train and develop IT Quality Assurance team. Strategically partner with PDM & Regulatory Compliance Quality Assurance groups. Completion and execution of Development Plans, Training Plans and Succession Planning development for all direct reports and management of all resources within the organization to provide top talent management practices.
  • Information Technology. Expert IT Quality assurance knowledge, approval of validation deliverables (requirement specifications, compliance/validation, protocols, validation summary reports and compliance/validation reports), SQA Methodologies, SDLC, and SOPs. system testing, user acceptance testing, traceability matrices, and design specifications.
  • Quality Assurance. Manage and direct IT’s efforts and deliverables for internal and external compliance audits, including those with regulatory bodies. Maintain expert knowledge of compliance & regulations associated with IT Quality Assurance. Manage all SOPs, policies, training records, validation protocols and controlled documents. Develop and maintain KPIs aligned to organizational goals.
  • Project Management.  Work closely with all Information Technology groups to ensure IT Quality Assurance is incorporated into the system lifecycle.

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