Join TechBio Companies Driving Patient Impact

Sponsored by Alix Ventures

Post a job // Join our newsletter
BIOS Community
BIOS Community

Senior Director, Strategy & Operational Excellence, Quality and Regulatory Affairs #2899



Legal, Sales & Business Development, Quality Assurance
Menlo Park, CA, USA
Posted on Wednesday, March 1, 2023
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
As the Senior Director, Strategy & Operational Excellence, Quality and Regulatory Affairs, you will be leading the development and execution of the Quality and Regulatory Affairs (Q&R) organization’s strategic plan, driving strategic initiatives (both internal and external), supporting the mission of a strategic and proactive Q&R organization and ensure operational excellence across the organization. This role will report to the SVP of Quality and Regulatory Affairs and will be a member of the Q&R senior leadership team. Additionally, this role will serve as a key advisor and provide strategic and operational leadership to help drive the company's success in meeting Q&R and business product goals.

You will:

  • Lead the development and execution of the organization’s strategic plan, working with the SVP, Quality & Regulatory Affairs, and the rest of the senior leadership team in crafting a long-term vision and roadmap for the organization.
  • Develop and implement key performance indicators (KPIs) to track progress against strategic and operational objectives.
  • Lead and champion Operational Excellence initiatives to drive process improvements, efficiency, and effectiveness at scale across Q&R processes and cross-functional engagements.
  • Champion innovation and transformation strategies with the design and execution of change management in operating models as Q&R scale.
  • Oversee and drive a portfolio of large and complex strategic programs and build specialized program management capabilities over time.
  • Build a platform to foster a culture of proactive collaboration, accountability, and innovation across the organization and cross-functionally.
  • Build reporting and intelligence capabilities to analyze industry insights and identify opportunities and risks with strategic recommendations to the SVP and the Quality & Regulation organization.
  • Act as an ambassador for senior leadership, helping to distill and cascade priorities to teams and partners.
  • Exhibit excellent judgment on sensitive and complex issues, fostering collaboration between leaders, teams, stakeholders, and related functions.

Your background should include;

  • Bachelor’s degree in Sciences or Engineering. A master’s degree is highly valued and preferred.
  • At least 15 years of experience in strategy and operations functions including experience in the biotech and/or medical device/IVD industry.
  • Six Sigma Black Belt, with leadership experience driving process improvement and operational excellence at a global scale.
  • Previous experience with leading portfolio and program management functions in highly-matrixed environments.
  • Previous experience working in a Chief-of-Staff capacity as an advisor to senior executives is preferred.
  • Previous experience with the development and implementation of strategy, goals, and metrics for a start-up organization and experience in the organic growth of a newer greenfield organization.
  • Strong strategic and analytical skills, with the ability to think critically, synthesize complex information, anticipate future risks, and make sound recommendations based on data and market insights.
  • Excellent leadership and communication skills, with the ability to inspire and motivate teams, build strong relationships with stakeholders, and communicate effectively with all levels of the organization.
  • Ability to effectively influence teams and programs without having direct oversightStrong business and financial acumen as well as experience in budget management, financial planning, and analysis
The expected, full-time, annual base pay scale for this position to be posted. Actual base pay will consider skills, experience, and location.
Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.
In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.
Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation for consideration by GRAIL.