Director Quality Audits

Overview

GRAIL is a healthcare company pioneering new technologies to advance early cancer detection. We build a multidisciplinary organization of scientists, engineers, and physicians and use next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to tackle one of medicine’s greatest challenges.
Our mission is to detect cancer early, when it can be cured.

Requirements:
Minimum of 60% or 3 days per week onsite in Durham, NC.

• Interface with individuals at all levels of the organization to conduct audits, report audit findings, facilitate and monitor the life-cycle of audit findings until completion, promote continuous improvement of systems, products, and services, and establish and maintain QMS systems that are in conformance with international and local requirements.
• Develop, manage and execute inspection readiness programs across the GRAIL QMS to ensure site readiness at all times, including inspection logistics and management preparation and execution and subject matter expert training, development and coaching; facilitate mock inspections as required.
• Manage and support external regulatory compliance inspections (CAP, NYSDOH, FDA, IVDR), responses, and action implementation follow-up; support internal audits by acting as an auditor or driving completion of audit actions when required; analyze and monitor quality data to identify potential high risks and implement necessary actions to mitigate compliance and product risk.
• Provide guidance to develop, implement, and maintain Quality Management Systems to ensure effective, efficient organization functioning, high level of regulatory compliance, achievement of company goals, and customer satisfaction.
• Develop and provide inspection execution related training in support of compliance systems and quality improvements.
• Partner with various internal and external groups to analyze problems, identify and communicate options, and recommend appropriate solutions; disseminate audit findings to senior management as required by the Corporate Quality System Audit Program.
• Develop and create audit reports, coordinate action plans, and follow up with auditee to assure prompt and adequate completion of agreed actions.
• Establish and conduct sectional readiness training for GRAIL functions; serve as GMP subject matter expert (SME) for regulatory inspections when needed.
• Lead contracted third‑party audit activities used for the Corporate Quality System Audit Program.
• Be responsible for the technical development of personnel, leading others through audits and ensuring the quality of deliverables within their purview; support corporate functions with expertise during third‑party investigations.
• Establish and maintain effective cross‑functional team communications to advance quality activities.
• Work on problems of diverse scope where data analysis requires evaluation of identifiable factors; demonstrate good judgment in selecting methods and techniques for obtaining solutions.
• Directly responsible for ongoing maintenance and continuous improvement of the audit program; assist with inspection activities (preparation, conduct, and responses) for Quality System inspections required by the Corporate Quality System Audit Program.
• Coach and mentor staff to ensure performance and professional development.
• Help develop and report quality and compliance metrics related to compliance audit activities.
• Hire, manage, develop, retain, coach, and mentor staff, including setting individual and team goals and conducting performance reviews.

• BA/BS and
  10+ years in Quality Assurance.
• Minimum of 10 years of GMP auditing experience in the medical device, pharmaceutical, or biotech industry.
• Experience in medical devices, manufacturing IVD, clinical diagnostic, CAP/CLIA, or similar experience is preferred.
• Extensive knowledge of good manufacturing, strong understanding of FDA, ICH and IVDR regulations and Quality Systems; solid background in Quality Assurance/Systems.
• Outstanding auditing skills and attention to detail with audit program implementation, including interpreting regulations,…