Director Data Integrity #3333

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

The Director of Data Integrity will lead the development and implementation of a robust Data Integrity Program across GRAIL. The program supports the integrity of GRAIL's GxP data through its entire life cycle and ensures compliance with regulatory and GRAIL requirements. This role will define and implement the Data Integrity program for all GxP data, whether it is manual or electronic, including ensuring that all GXP computerized systems across the end-to-end product lifecycle meet Data Integrity principles. This leadership role will implement a quality system that assures regulatory compliance, product quality and patient safety related to Data Integrity that ensures Data Integrity and detects, investigates and corrects.

You will:

• Serve as the Data Integrity leader in Clinical Quality Assurance and provide strategic leadership for the establishment of a robust Data Integrity program building on work completed.
• Lead the development and implementation of a robust Data Integrity Program across GRAIL, including global clinical studies
• Provide global strategic and operational mentorship on Data Integrity standards (e.g., FDA, MHRA, EMA)
• Incorporate Data Integrity training and standards in all GxP environments and functional area policies and procedures
• Advise on computer system validation requirements and standard methodologies (21 CFR Part 11, Agile)
• Able to build alignment with business partners including Clinical, Software/IT, Research and Commercial Operations leaders.
• Ability to demonstrate strategic thinking capability with a strong project management focus as well as focus on the execution of strategic decisions while balancing conflicting priorities.
• Represent Clinical Quality Assurance across governance and strategic committees
• Support regulatory submissions and regulatory inspections related to clinical data
• Lead Data Integrity-related responsibilities in Clinical Quality Assurance's annual audit planning process
• Help plan, conduct, report on and follow up on Clinical Quality Assurance audits

Your qualifications and background will include:

• Bachelor's degree required
• Advanced degree preferred
• At least 10 years of relevant industry experience
• Data integrity experience in a human pharmaceutical or medical device company
• Experience managing staff in a global setting
• Specialist in FDA/ICH/GCP principles related to clinical studies
• Significant computer system validation experience
• Extensive knowledge of GxP environments
• Experience supporting health authority inspections
• Global clinical trial expertise and a track record of leading through influence, and working across global organizational matrices

The expected, full-time, annual base pay scale for this position is $176,000 - $235,000

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 Office and Affirmative Action 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.