About the Job

The Senior Director Quality Assurance (QA) will work as part of a new product team, focused on improving blood-based cancer diagnostic capabilities in areas such as cancer detection, minimum residual disease, and other related applications. This team is comprised of talent from across the Roche ecosystem, including Roche Diagnostics, Roche Pharma and Foundation Medicine, operating as a single unit. 

The Senior Director Quality Assurance is responsible for the development and implementation of a comprehensive quality strategy for a new portfolio of assay products, both centralized and distributed. This role will have the opportunity to contribute at the ground level to the overall development and delivery of program strategy for this new portfolio, provide insights for decision-making, and lead quality assurance initiatives. 

Key Responsibilities

• Drive cross-functional collaboration and a culture of quality: 
  • Establish strong partnerships with leaders across Roche and FMI to enable the program and portfolio 
  • Strategically represent Quality Assurance on enterprise initiatives leadership team 
  • Contribute as a thought-partner for innovative global strategy in a changing regulatory landscape 
  • Ensure that cross-functional teams are trained and have a working understanding of internal policies and procedures, and quality best practices 
• Optimize and implement fit-for-purpose QMS solutions: 
  • Design QMS procedures to effectively meet business objectives and meet FDA QSR, IVDD/IVDR, ISO, CAP/CLIA, NYS and other applicable regulations and guidelines 
  • Identify, evaluate, and propose tools to implement QMS process (requirements management, document management, risk management, etc.) 
    • Evaluate different solutions, including timeline to implementation, cost, resource requirements, and ease of use 
• Lead Quality Assurance activities for centralized and decentralized IVD development, including commercialized software solutions 
  • Coach and mentor Quality personnel supporting the program from across the Roche organization 
  • Define quality assurance milestones from research phase through launch for centralized and externalized IVDs 
  • Define quality assurance milestones for establishment of a CLIA laboratory 
  • Guide Development teams through development and verification and validation stages of design control 
  • Lead team through risk management and implement a risk-based approach for continuous improvement 
  • Ensure that design, development, verification, and validation are performed and documented in a compliant manner to support global marketing authorizations 
• Maintain Knowledge of Evolving Compliance Landscape: 
  • Maintain awareness of changing regulations with ability to assess the impact on projects and make modifications as necessary 

Qualifications

Basic Qualifications

• Bachelor’s Degree and 12+ years of demonstrated experience in medical device and lab developed tests or digital product, pharmaceutical/biologics quality assurance, or scientific discipline including at least 5 years of demonstrated leadership experience specifically in quality assurance

OR 

• Advanced Degree in science, law, health policy, regulatory affairs or engineering and 10+ years of demonstrated experience in device, pharmaceutical/biologics quality assurance, or scientific discipline including at least 4 years of demonstrated experience specifically in quality assurance work 

Preferred Qualifications

• Masters or Advanced Degree in a science, law, health policy, regulatory affairs or engineering discipline 
• 12+ years of professional work experience in a molecular testing laboratory, diagnostic manufacturing organization and/or a diagnostics service organization 
• 6+ years working in a quality assurance department supporting globally marketed in vitro diagnostics, including those regulated by US FDA, IVDD/IVDR, and Japan. 
• Experience hosting audits by FDA, PMDA, EMA, CAP, or other regulatory bodies 
• Experience building, optimizing, and implementing quality management systems that work within FDA device regulations, IVDD/IVDR, ISO, CAP/CLIA, and NYS regulations and guidelines 
  • Experience building and implementing quality systems within a CLIA lab especially preferred 
• Demonstrated ability to work to drive clarity and deliver results in the face of ambiguity or a start-up environment 
• Must be both an architect AND a do-er, with the ability to strategize and deliver artifacts 
• Experience in multifunctional work environment and ability to lead development and execution of complex plans across multiple priorities 
• Enterprise mindset 
• Ability to influence and negotiate effective solutions through leading change and driving for results 
• Strong analytical skills and ability to apply strategic-thinking and problem-solving skills to meet business objectives 
• Guiding Development teams on designing, developing, and validating with quality, risk evaluation, meeting lab and health authority agency requirements 
• Strong focus on applying risk-benefit analyses to solve problems 
• Outstanding presentation and communication skills 
• Strong history of achievement demonstrated by leadership activities and other achievements 
• Collaboration skills and the ability to effectively communicate (written and oral) with internal and external team members 
• Highly effective teamwork and collaboration skills; a team player 
• History of leadership and track record of applying strategic and systems thinking 
• Experience and understanding of both US and ex-US regulatory registrations, approvals, and maintenance activities 
• Understanding of HIPAA, GDPR, and importance of patient safety and data privacy regulations and guidelines 
• Commitment to FMI’s values: innovation, patients, collaboration, and passion.