Senior / Staff Data Integrity Engineer # 4942

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