Associate Director, Quality Process # 4648

GRAIL•Durham, NC

9d•$146,000 - $183,000•Hybrid

About The Position

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicineâs greatest challenges. GRAIL is headquartered in the bay area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com The Associate Director, Quality Process provides strategic and operational leadership for the quality function, ensuring that products, processes, and systems meet the highest standards of compliance, reliability, and customer satisfaction. This role defines and executes quality system strategies, leads cross-functional initiatives, and oversees quality system operations across multiple teams or sites. The position acts as a leader within the organization, guiding quality culture, driving continuous improvement, and ensuring readiness for regulatory and customer audits. This role is based at our Durham, North Carolina, office. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 60% requirement for the site.

Requirements

Bachelor's degree in Engineering, Quality Assurance, Industrial Technology, or a related field; Master's degree strongly preferred.
12+ years of experience in quality engineering, process engineering, or manufacturing, including 5+ years in a leadership or management role.
Demonstrated success leading quality organizations through audits, regulatory inspections, and customer assessments.
Strong knowledge of global quality management systems, regulatory compliance frameworks, and industry standards.
Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include:
GMP quality management systems (e.g. ISO 13485)
Risk assessment frameworks (e.g. ISO 14971)
Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)
Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)
Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56)

Nice To Haves

Strategic leadership skills with the ability to align quality initiatives to business objectives.
Expertise in advanced quality engineering tools and methodologies (FMEA, DOE, SPC, Six Sigma, Lean).
Strong organizational change management and continuous improvement capabilities.
Excellent communication and executive presentation skills, with experience influencing senior leadership.
Proven ability to lead and develop high-performing teams across multiple levels.
Financial and operational acumen to manage budgets, resources, and cross-functional priorities.

Responsibilities

Develop and implement long-term quality system strategies, policies, and objectives aligned with organizational goals.
Lead multiple quality teams, including engineers, technicians, and managers, providing direction, coaching, and career development.
Oversee quality assurance and compliance programs to ensure adherence to internal standards, customer expectations, and regulatory requirements.
Partner with senior leadership across the company to improve processes and enhance product quality.
Lead organizational readiness for external audits, inspections, and customer assessments, serving as the senior quality representative.
Analyze enterprise-level quality performance metrics, identify systemic risks, and implement strategic solutions.
Drive continuous improvement initiatives across functions to enhance efficiency, reduce risk, and improve quality outcomes.
Influence product development and lifecycle processes by embedding quality into design, validation, and manufacturing.
Represent the organization with customers, regulatory agencies, and external partners on quality matters.