Director of Software Verification & Validation, Software and Bioinformatics

  • icrunchdata Network
  • California, KY, USA
  • Nov 25, 2021
Information Technology (IT)

Job Description

Director of Software Verification & Validation, Software and Bioinformatics The Director of Software Verification & Validation will help define, maintain, and carry out Roche Sequencing Solutions’ verification and validation vision for the Software and Bioinformatics organization ensuring our verification activities remain efficient and agile, while meeting all compliance requirements. You’ll assess risks and hazards, ensure safe and effective design and development procedures, and evolve the quality standards of our instruments and analytics software teams. Additionally, you’ll promote and implement state of the art methodologies for software verification testing aligned to modern agile software development best practices. Activities: Develop and implement software testing methods and best practices that allow high quality NGS analytics and instruments software products to be designed, developed and released into the regulated in-vitro diagnostics/ medical device space. Establish software quality standards and KPI metrics to actively measure software and bioinformatics product quality. Implement software quality tracking tools and methodologies to provide on-going visibility and actionability during software product development lifecycle. Partner with software and bioinformatics leadership, functional and project managers to identify appropriate scope of software testing, verification and validation required for a project and managing the overall testing activities for projects Manage the definition of test methods and the creation of test plans for new or updated software to ensure it will perform accurately and reliably according to documented requirements as well as established standards under both normal and abnormal conditions. Maintain effective communication with the engineering, quality & regulatory, operations, and executive leaders on product risks, quality status and progress. Effectively communicate knowledge of company's vision, organizational, philosophy, values and code of ethics to the software test, verification and validation organization Promote agile software development best practices and test-driven development culture Qualifications: Minimum 10 experience performing software verification and validation testing, preferably in the medical device/ biotech space. Strong leadership abilities and extensive experience managing the activities of software quality engineering and assurance teams Practical experience as a leader in the use of modern software development methodologies/ processes with an ability to direct the use of resources to meet department goals Knowledge of software technology industry trends, considerations and emerging technologies Extensive experience in design control for regulated products (e.g. US-IVD) and knowledge of applicable regulations and standards used in IVD and medical device software development (e.g. ISO 13485, IEC 62304, and 21 CFR 820) Demonstrated ability to work well with senior leadership Experience leading cross-functional, multi-site teams Experience working in a fast paced, dynamic environment Preferred: prior product security or information security experience Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. If you have a disability and need an accommodation in connection with the on-line application process, please email us at . This website contains information on products which is targeted to a wide range of audiences and could contain product details or information otherwise not accessible or valid in your country. Please be aware that we do not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin.

Job ID

F. Hoffmann La Roche Gruppe


200.000 - 250.000