Director Quality Audits # 4413

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 medicine’s greatest challenges.

GRAIL is headquartered in Menlo Park, 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.

As a key member of the Quality Leadership Team, the Director of Quality Audits will be responsible with overall leadership and implementation of GRAIL’s Global Audit Management Program (Internal, External, Supplier) compliance designed to address all aspects of the Product Development Lifecycle supporting functions, including: Manufacturing Operations, Clinical Laboratory Operations, Program Management, Supply Chain, Materials Management, Process Engineering, Supplier Quality and Logistics.

• Interface with individuals at all levels of the organization to conduct audits at specified intervals and report audit findings, facilitate and monitor the life-cycle of audit findings until completion, promote continuous improvement of systems, products, and services, 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 logistic and management preparation and execution and subject matter expert training, development and coaching.  Facilitate Mock inspections as required to ensure a state of readiness. 
• Manage and support the 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 and analyze and monitor quality data to identify potential high risks and implement necessary actions to mitigate compliance and product risk.
• Provide guidance to assist in the development, implementation, and maintenance of the Quality Management Systems to ensure the organization functions effectively and efficiently in order to ensure a high level of Regulatory Compliance and to achieve Company goals, objectives, and policies as well as satisfy customer requirements.
• Develops and provides inspection execution related training in support of compliance systems and quality improvements.
• Partners with various internal and external groups to help analyze problems, identify and communicate options, and recommend appropriate solutions. Disseminates audit findings to senior management as required by the Corporate Quality System Audit Program.
• Develops and creates audit reports, coordinates action plans, and follow-up with auditee to assure prompt and adequate completion of agreed upon actions.
• Establishes and conducts sectional readiness training for GRAIL functions Serves as GMP subject matter expert (SME) for regulatory inspections, as needed.
• Leads contracted 3rd party audit activities used for supporting the Corporate Quality System Audit Program.
• Responsible for technical development of personnel, leading others through audits and ensuring the quality of deliverables within their purview. Supports corporate functions with expertise and assistance as they undergo 3rd party investigations is also required.
• Establishes/maintains effective cross-functional team communications to advance quality activities.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Directly responsible for ongoing maintenance and continuous improvement of this audit program. Assists with inspection activities (preparation, conduct, and responses) for Quality System inspections required by the Corporate Quality Systems Audit Program, which includes auditing company manufacturing sites and corporate quality system functions encompassed at various GRAIL facilities.
• Coaches/mentors staff as a means to ensure performance and professional development.
• Helps development and reporting of quality and compliance metrics related to Compliance audit activities.
• Hiring, managing, developing, retaining, coaching and mentoring staff including setting individual and team goals and conducting performance reviews.

• BA/BS and10+ years in Quality Assurance.
• Minimum of 10  years of GMP auditing work 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, guidelines, and identification of compliance issues.
• Demonstrated broad expertise related to the principles and application of quality and regulatory compliance.
• Displays highly developed organizational leadership qualities and effective coaching abilities.
• Listening, interpreting, and summarizing information skills must be highly developedExcellent communication and writing skills; Proactive, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships.
• Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view.
• Must be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety Manual.

Expected full time annual base pay scale for this position is $167K - $239K. 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 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.