Associate Director Quality Process 4648

Associate Director Quality Process

4648 Durham, NC Research & Development - Quality & Clinical Compliance Full-Time Hybrid apply for this job

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 medicines 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

Job Description

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 GRAILs 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.

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.

These job duties are a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the companys discretion.

Required Qualifications

• Bachelors degree in Engineering, Quality Assurance, Industrial Technology, or a related field. Masters 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 positions 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)

Preferred Qualifications

• 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.

Physical Demands and Work Environment

• Work performed in office, production, and laboratory environments, frequent cross-functional engagement.
• Travel may be required to support audits, inspections, or collaboration with global teams and suppliers.
• Regular use of PPE in production and laboratory settings.
• Standard weekday schedule with flexibility for extended hours during regulatory inspections, customer visits, or critical investigations.

Compensation and Benefits

• The expected full-time annual base pay scale for this position is $146,000 - $183,000. Actual base pay will consider skills, experience, and location.
• This role may be eligible for other forms of compensation, including an annual bonus and/or incentives, subject to the terms of the applicable plans and Company discretion.
• Employees in this role are also eligible for GRAILs comprehensive and competitive benefits package offered in accordance with our applicable plans and policies. This package currently includes flexible time-off or vacation, a 401(k) retirement plan with employer match, medical, dental, and vision coverage, and carefully selected mindfulness programs.

Equal Employment Opportunity

GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability status as a protected veteran, or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at emailprotected if you require an accommodation to apply for an open position.

GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us. apply for this job