Senior IT Quality Consultant
This is a senior-level position that provides consultation and direction to functional areas, including Software Quality and DevOps teams, on IT Quality policy, process, and procedures.
Key Responsibilities:
* Ensure IT validation packages comply with applicable Corporate and Divisional Policies and procedures.
* Support Software Development teams as SQA lead for the automated testing and implementation of regulated IT applications.
* Coordinate the introduction of new strategic methodologies; supports and approves the overall validation of global regulated applications.
* Drive the GXP Inspection Support and defend the validation strategies to internal auditors, regulatory authorities, and other certified bodies.
Requirements:
* Bachelor's Degree in Computer Science, Information Technology or equivalent plus 8+ years of related work experience with IT Quality in the life science industry.
* Certifications from ASQ and ISO9001 or ISO13485 preferred.
Desirable Skills:
* Strong knowledge of GXP regulations and software validation principles.
* Working knowledge of risk management principles, regulatory requirements, and industry best practices.
* Familiarity with Agile, Lean software development practices, and automated testing and implementation.