Senior / Staff Data Integrity Engineer # 4942

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

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 rc@grailbio.com 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!