Senior Manager of Quality

Organization
Roche NimbleGen
Job Location
Madison, WI
Benefits

See our generous and comprehensive benefit package at USRocheBenefits.com!

Job Description

Position Responsibilities:

  • 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.
Requirements

Knowledge/Skills/Attributes:

  • Required: Bachelor's degree in engineering or a scientific discipline AND 5 years of Quality Assurance/Systems Experience
  • Required: Practical knowledge of quality engineering practices and understand of applicable industry regulations and quality standards
  • Required: Working knowledge of ISO 9001
  • Required: Strong time management, interpersonal, and organizational skills
  • Required: High aptitude for troubleshooting and problem solving
  • Required: History of exceptional work quality and results
  • Required: Demonstrated leadership skills
  • Required: Excellent written and verbal communication skills
  • Required: Previous success in achieving measurable quality improvements
  • Required: Superior facilitation skills with proven ability to maintain positive working relationships
  • Required: Analytical approach to issues in a wide range of complex situations while meeting Quality Management System (QMS), regulatory, and business requirements
  • Preferred: Working knowledge of 21 CFR 820 and cGMP
  • Preferred: Experience in an FDA regulated industry
  • Preferred: Experience working in a global, matrixed, and complex organization

Physical Requirements:

  • Lift and turn, up to 5 pounds
  • Perform repetitive motion and operate a computer keyboard
  • Work in groups or alone and/or in a close or cubical environment
  • Sit and/or stand for extended periods of time
  • Speak, read, write and understand English and follow spoken and written instructions
About Our Organization

Roche NimbleGen, an innovator in genomics, is focused on developing target enrichment solutions for next-generation sequencing. Our technologies allow researchers to selectively target DNA or RNA sequences of interest in human or non-human genomes, either through focused exomes, transcriptomes or custom designed gene panels for variant discovery and validation. With our ever growing suite of tools for targeted DNA sequencing, we are enabling the life science community to achieve their research goals more efficiently in order to understand the association genomics and epigenomics have with diseases and biological processes.

As pioneers in sequencing with a rich heritage in diagnostics, Roche's Sequencing Unit is committed to a future that fosters innovation to provide solutions that enable scientific discovery and deliver clinical value – We are Changing Science and Changing Lives.

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