Senior / Staff Data Integrity Engineer # 4942

GRAIL; Sunnyvale (CA); On-site; USD 135,000 - 180,000; Full time

Benefits offered by this job

Flexible time off

401(k) match

Medical, dental, vision

Job summary

GRAIL seeks a Senior / Staff Data Integrity Engineer to ensure ALCOA+ data integrity in the data life cycle under the Data Integrity Office. You will act as a subject matter expert, perform risk assessments, and implement Data Integrity requirements to support regulatory compliance, product quality, and patient safety.

This cross-functional role requires collaboration across Clinical Development, Software/IT, and Manufacturing, with a focus on audits, CAPA, and change control activities to

Qualifications

• Experience in a GxP environment with data integrity.
• Knowledge of risk and impact assessments in regulated settings.
• Familiarity with GMP/Quality systems and regulatory standards.

Responsibilities

• Support implementation and execution of the GRAIL Data Integrity Program.
• Act as Data Integrity SME within the organization; lead reviews and reporting.
• Identify data integrity risk within CAPA, non-conformances, clinical quality events, and change control.
• Represent Data Integrity interests for supplier, internal and 3rd party audits.
• Collaborate with Clinical Development, Clinical Lab, Software/IT, Research, Manufacturing, and other partners.
• Demonstrate strategic thinking with strong project management and balancing priorities.

Skills

GxP Validation

Data Integrity

Regulatory Compliance

Risk Assessment

21 CFR Part 11

Education

BS/BA + 5+ yrs

Masters + 3+ yrs

Tools

CAPA systems

Job description

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 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

As a Senior / Staff Data Integrity Engineer you ensure that GRAIL data within scope of the Data Integrity Policy meets the ALCOA+ attributes. As part of the Data Integrity Office you function as Subject Matter Expert (SME) on Data Integrity topics throughout the data life cycle. You prepare and help with the correct implementation of Data Integrity Requirements, apply Data Integrity principles, perform risk assessments and provide SME support for the correct identification of Data Integrity Impact and Data Integrity Risks within QMS processes. This is a cross functional role that assures regulatory compliance, product quality and patient safety related to data integrity that ensures data integrity and that detects, investigates and corrects where needed.

Responsibilities:

• Support the implementation and execution of the GRAIL Data Integrity Program
• Act as Data Integrity Subject Matter Expert within the organization
  • Perform quarterly Data Integrity reviews and generate quarterly reporting
  • Identify Data Integrity risk and/or impact within following processes: CAPA, Non-conformances, Clinical Quality Events, Clinical Protocol Deviations and Change Control Activities
  • Represent Data Integrity interests for supplier, internal and 3rd party Audits
• Able to build alignment with business partners within GRAIL including Clinical Development, Clinical Lab, Software/IT, Research, Manufacturing, Warehouse, Facilities, and Commercial Operations leaders
• Ability to demonstrate strategic thinking capability with a strong project management focus while balancing conflicting priorities
• Enhance relationships and networks with senior partners who are not familiar with the subject matter often requiring persuasion
• Adapt style to different audiences and advise others on difficult matters

Required Qualifications:

• The right candidate for this position has a strong background in either GxP Computer system validation or a technical background (IT, SW Development,Clinical Data Management, Data Sciences....) with proven hands on work experience in a GxP environment and data integrity in a GxP context..
• BS/BA degree & 5+ years of related experience or Masters & 3+ years of related experience (pref Life Science, Engineering or Computer/Tech degree)
• Experience includes:
  • Data integrity/ALCOA+/Data Sciences experience in a human pharmaceutical or medical device company
  • Good understanding of Risk and Impact assessments
  • Experience working in a GxP environment
  • Computer System Validation experience, including sound knowledge of 21 CFR Part 11
• Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's 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)
  • Protected health information (e.g. HIPAA, GDPR)
  • Regulatory submission of medical devices (e.g. IVDD, IVDR, FDA 21 CFR, UK MDR 2002)
  • 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:

• Excellent communications skills
• Strong Documentation Skills
• You are analytical, can set priorities, have a sense of planning and can work independently
• Quality minded

The expected, full-time, annual base pay scale for this position is $135K - $180K. Actual base pay will consider skills, experience, and location.

At GRAIL, we believe in recognizing and rewarding the contributions our employees make to our mission and success. In addition to base pay, this role may be eligible for additional compensation, including an annual bonus and/or other incentives, in accordance with applicable plans and the company's discretion. The posted range reflects our good-faith estimate of the base pay we expect to offer for this position at the time of hire. Actual compensation will be determined based on factors such as the candidate’s experience, skills, qualifications, and other relevant considerations.

At GRAIL, we invest in the health, well-being, and future of our employees and their families. Employees in this role are eligible for a comprehensive and competitive benefits package designed to support what matters most, including flexible time off or vacation, a 401(k) retirement plan with employer match, medical, dental, and vision coverage, and thoughtfully selected well-being programs. Benefits are offered in accordance with applicable plans and policies.

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 [e-mail] 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!