Associate Director, Quality Systems

Remote - USA /
Quality /
Full-Time
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 part of the Quality organization, the Associate Director, Quality Systems will be responsible for managing the maintenance, delivery, and continuous improvement of GRAIL’s Quality Systems program by combining an ability to foster engagement and advance key programmatic initiatives with an understanding of quality processes. This individual will provide support and subject matter expertise for multiple functional areas representative of all elements of GRAIL’s Quality Systems program. This position will report to the Director, Quality Systems and can work remotely, but must be able to work from GRAIL facilities on an as-needed basis.

You will:

    • Contribute to the implementation and design of GRAIL’s Quality Systems program for cross-functional, localized, and other corporate quality initiatives.
    • Provide quality guidance and direction on cross-functional teams throughout the development cycle and identify/coordinate cross-functional deliverables for submissions to ensure that product and customer requirements are met.
    • Develop and revise company policies and procedures in support of IVDR, SO13485, CAP/CLIA, NYSDOH, and FDA, in collaboration with key partners.
    • Execute Quality Review to ensure that records and quality events align with GDP and regulatory requirements and initiate risk-based assessment and audits to ensure compliance with current standards and resolution of issues alongside key partners.
    • Maintain ownership of the product roadmap and risk assessment strategy for GRAIL’s electronic quality management system (eQMS), including supporting computer system validation (CSV) efforts, as needed.
    • Investigate and resolve Quality System issues with cross-functional teams applying root cause analysis; promote continuous process improvement and operational excellence within the Quality Systems program.
    • Develop inspection readiness strategy and procedures for their respective site, including documentation, training materials, and other resources; complete and provide support for internal and external audits, as needed.
    • Manage generation of management reports including key performance indicators (KPIs), metrics, and trends; work with partners to identify and implement improvement projects.
    • Act as Quality Systems representative, developing and maintaining positive relationships with internal customers, regulatory agency reviewers and vendors through oral and written communications.
    • Manage and oversee Quality Systems vendor relationships and accounts, as assigned, providing cross-functional subject matter expertise.
    • Lead Quality Systems Specialists and Coordinators via coaching, encouragement, and evaluation to ensure quality and company objectives are met.
    • Achieve financial objectives by assisting in preparing the Quality Systems budget, scheduling expenditures, analyzing variances, and initiating corrective actions.

Your background and qualifications will include:

    • Bachelor’s degree in a scientific or related field required. 12+ years of quality experience working in a biotechnology, healthcare, or other regulated environment.
    • Proven background in quality procedures, processes, and guidelines, and the ability to interpret and operationalize quality system regulations.
    • Experience with the following: 21 CFR 820, ISO 13485, IVDR, CAP/CLIA/NYSDOH, and ICH/GCP preferred.
    • Clear ability to work well under pressure with a proactive approach, including managing multiple priorities, deliverables, and deadlines.
    • Requires, strong analytical skills and a passion for solving problems via collaboration and a growth mindset.
    • Strong and effective written and oral communication skills across all levels of the organization, with a diverse group of individuals.
    • Ability and passion to provide excellent internal and external customer service.
    • Team-oriented approach with proven ability to quickly and consistently establish rapport and collaborate effectively with key stakeholders, cross-functional partners, and leadership.
    • Excellent organization and time management skills.
    • Proficiency with standard office software applications including Google Suite, Microsoft Suite, and Zoom; prior electronic quality management system (eQMS) and experience using Veeva Vault preferred.
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.

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. 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.