Director Quality Audits # 4413 at GRAIL

Durham, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, BiotechnologyIndustries

Requirements

Experience leading and implementing global audit management programs (internal, external, supplier) in compliance with QMS for product development lifecycle functions (e.g., manufacturing, clinical labs, supply chain)
Ability to interface with all organizational levels, conduct audits, report findings, and manage audit lifecycle to completion
Expertise in developing, managing, and executing inspection readiness programs, including logistics, SME training, mock inspections
Knowledge of managing external regulatory inspections (e.g., CAP, NYSDOH, FDA, IVDR) and internal audits
Proficiency in analyzing quality data, identifying risks, and implementing mitigation actions
Skills in providing guidance for QMS development, implementation, and maintenance to ensure regulatory compliance and organizational goals
Capability to develop and deliver inspection-related training and serve as GMP SME
Experience partnering with internal/external groups to analyze problems, recommend solutions, and disseminate findings to senior management
Ability to develop audit reports, coordinate action plans, and ensure completion
Leadership in technical development of personnel, leading audits, ensuring deliverable quality, and supporting 3rd party investigations
Strong cross-functional communication skills

Responsibilities

Provide overall leadership and implementation of GRAIL’s Global Audit Management Program (Internal, External, Supplier) across product development lifecycle functions
Interface with all organizational levels to conduct audits, report findings, facilitate/monitor audit lifecycle, promote continuous improvement, and maintain compliant QMS
Develop, manage, and execute inspection readiness programs, including logistics, SME training/coaching, and mock inspections
Manage/support external regulatory inspections (CAP, NYSDOH, FDA, IVDR), responses, action implementation, and follow-up
Support internal audits as auditor or driver of action completion; analyze/monitor quality data for risks and mitigation
Guide development, implementation, and maintenance of QMS for regulatory compliance, efficiency, and customer satisfaction
Develop and provide inspection execution training for compliance and quality improvements
Partner with internal/external groups to analyze problems, identify options, recommend solutions, and disseminate audit findings to senior management
Develop audit reports, coordinate action plans, and follow-up with auditees for completion
Establish and conduct sectional readiness training; serve as GMP SME for inspections
Lead contracted 3rd party audit activities for the Corporate Quality System Audit Program
Drive technical development of personnel, lead through audits, ensure deliverable quality, and support corporate functions with 3rd party investigations
Establish/maintain effective cross-functional team communications to advance quality activities

Skills

Quality Audits

QMS

Internal Audits

External Audits

Supplier Audits

Inspection Readiness

Compliance

Continuous Improvement

Audit Management

Manufacturing Operations

Clinical Laboratory Operations

Supply Chain

Process Engineering

Supplier Quality

GRAIL

Develops blood tests for early cancer detection

About GRAIL

GRAIL focuses on improving cancer detection through advanced blood tests that identify cancer at its earliest stages, enhancing treatment success rates. The company utilizes high-intensity sequencing to analyze tumor genome data, employing algorithms and deep learning to extract actionable information for early cancer detection. GRAIL differentiates itself from competitors by its commitment to large-scale clinical studies that validate the effectiveness of its tests. The primary goal is to reduce global cancer mortality by enabling early diagnosis, making the disease more treatable.

Menlo Park, CaliforniaHeadquarters

2016Year Founded

$1,765.5MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.

Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.

Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.

Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.

Risks

Potential overdiagnosis could impact the perceived value of GRAIL's tests.

Significant net losses may affect investor confidence and long-term sustainability.

High test costs may limit accessibility in markets with less healthcare funding.

Differentiation

GRAIL uses high-intensity sequencing for early cancer detection via blood tests.

The Galleri test screens for over 50 cancers with a single blood draw.

GRAIL's tests are supported by large-scale clinical studies ensuring reliability.

Upsides

Collaborations with platforms like Function Health expand Galleri test accessibility.

Revenue from Galleri grew 52% year-over-year, indicating strong market demand.

GRAIL's technology aligns with trends in personalized and preventative medicine.

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