Senior Director Software Quality # 3181 (RTP, NC)

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.
As a key member of the quality team at GRAIL, the Sr Director, Software Quality Assurance will be responsible for leading Design Control and Quality Assurance efforts for software product lifecycle management. The successful candidate will manage all elements of software development lifecycle and product Quality Assurance documentation; risk management, development & design planning, test verification, computer system validation, software assurance, change control, specifications, SOPs, protocols, and reports. This individual will lead and/or support all software quality engineering, qualification and validation activities of the software product life cycle and maintain a Design History File (DHF) for GRAIL’s devices in accordance with the approved design plan, procedures and regulations.  The individual will apply “systems” thinking and knowledge of systems, reliability, risk management, standards and design V&V engineering, test method development principles, practices and implementation to support new and sustaining projects. They will establish the vision, develop procedures, and facilitate the execution of activities within GRAIL. They will work creatively and collaboratively to engineer fit-for-purpose processes compliant with Quality regulations.

You will:

• Collaborate with functional leads to design and build Quality System processes to work with GRAIL’s existing systems and product pipelines.
• Design, develop, approve, and implement Software Development Lifecycle SOPs, work instructions, forms, reports, protocols, and documents associated with design control and Computer System Validations processes.
• Approve changes to process and new design activities.
• Provide QA support for Software Test from feasibility through transfer into commercialization.
• Perform and review/approve design control and risk management activities. 
• Work closely with research and development organizations to ensure potential product issues are identified and addressed in the design.
• Lead US and UK SW Quality teams ensuring procedural standardization and compliance.
• Conduct risk assessments and create/revise risk management documents as required by Standard Operating Procedures and other medical device regulations.
• Lead assessment of hazard analyses, design risk assessments, use of risk assessments, system risk assessments, and process risk assessments.
• Work with product development teams to assess design changes from a systems perspective, identifying risks, delivering design mitigations and evaluating the effectiveness of the risk control measures.
• Represent the company as a Software Quality Assurance subject matter expert during internal and external regulatory inspections.
• Ensure software design control documentation and requirements are met.Work on complex technical problems, utilize quality engineering methods and provide innovative solutions.
• Monitor, track/trend all KPI and periodically provide a summary report to Senior management including participation in Quality Management Review meetings and Product Lifecycle meetings.
• Facilitate Design review activities, process capabilities, including validation in partnership with Engineering, Product/Program team, and Clinical Development team, etc.
• Provide coaching to QA, product development key stakeholders personnel on Quality Systems requirements and process improvement methodologies.

Your qualifications and background will include

• Minimum of a Bachelor of Science Degree in Engineering or scientific field with at least 12 years of software quality assurance and validation experience in the medical device or CDx (combination products) industry.
• 10 years of progressive people management experience.
• At least 10 years of direct managerial responsibility leading all aspects of Design Control and Validation for Software and/or Medical Devices
• Extensive experience and understanding of design, development, verification and validation processes.
• Exceptional working knowledge and