- Responsible for the development, maintenance, and improvement of the Roche NimbleGen Quality Management System. Ensures alignment with strategic goals, global quality system standards, federal regulations and standards.
- Maintain NimbleGen's ISO-9001 certification and compliance.
- Maintain strong ownership of all quality processes at NimbleGen, provide quality assurance for design and operations processes. Continually monitor the effectiveness of all QMS procedures and drive improvements when called for.
- Responsible for key departmental quality processes (e.g. controlled document management, change management, CAPA, non-conforming materials, deviation management, internal quality audit, training and supplier/vendor quality assurance).
- Responsible for internal Quality system audit program and ensure appropriate, effective corrective action plan development and implementation.
- Provide Quality representation on new product development, cross-functional, and multi-site teams, assuring that QMS, regulatory, product and process quality requirements are met.
- Responsible for the provision and analysis of Quality System metrics for Management Reviews.
- Manage Quality team staff.
- Mentor peers serving as subject matter expert on quality systems, processes, and issues.