IT Quality Engineering Manager – Quality & Compliance

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Foster City, CA
Job Type
Direct Hire
Apr 18, 2018
Job ID
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This opportunity will offer you the chance to grow your experience and allow the individual to work on supporting the compliant delivery of next generation IT systems. You will independently identify project and general compliance risks; develop mitigation strategies.

 Essential Functions:
  • Conducts GxP risk assessments and applies risk assessment methodologies and tools.
  • Provides QA approvals and oversight of GxP deviation, CAPA and change records and ensures a structured approach for failure investigation and identification of root cause is followed.
  • Prepare IT staff for regulatory inspection and coaching of IT staff in the application of standard operating procedures for IT infrastructure compliance lifecycle management, good documentation practices and document control principles.
  • Contribute to operational and process improvement initiatives related to IT Quality and Compliance.
  • Review and approve validation and qualification deliverables for medium-to large-sized projects.
  • Perform wide variety of activities to ensure compliance with quality systems, quality procedures and applicable regulatory requirements.
  • Provide accurate work estimates for QA activities to project manager. Anticipate changes and escalates accordingly.
  • Identify and onboard qualified external resources assign tasks and monitor task execution.
  • Responsible for ensuring readiness for regulatory audits and inspections involving IT staff; host internal quality audits.
Education & Experience:
  • Minimum of 8 years of relevant experience and BA/BS degree, or equivalent OR
  • 6 years of relevant experience with advanced degree or equivalent.
  • Demonstrates an in-depth understanding and application of GxP principles, concepts, practices and standards
  • Demonstrated experience with the implementation or oversight of current validation systems in the pharmaceutical industry
  • Knowledge and experience in quality assurance in a highly regulated GxP environment.
  • Knowledge and experience in Vendor Management, Vendor Oversight and Audit hosting are desirable.
  • Excellent verbal, technical writing and interpersonal communication skills are required.
  • Experience in Life Sciences is mandatory

Identifier: $TECH, $NEER