Data Integrity Expert

Role Overview

The position aims to embed stringent Data Integrity practices in every facet of the site's operations, ensuring alignment with both regulatory standards and global quality mandates. This role involves cascading these critical requirements to various site functions to guarantee comprehensive adherence.

Primary Responsibilities

• Ensure all work complies with applicable Data Integrity regulatory standards and company policies.
• Carry out routine data quality assessments and validations to detect and rectify any integrity issues.
• Design and conduct instructional programs to educate staff on Data Integrity concepts and best practices.
• Identify potential risks associated with data integrity and implement strategies to mitigate them effectively.
• Maintain thorough documentation procedures for data recording, storage, and retrieval processes.
• Investigate any incidents impacting data integrity such as breaches or falsifications, and oversee the implementation of corrective and preventive action plans.
• Drive continuous improvement projects to enhance Data Integrity frameworks.
• Supervise validation processes for computerized systems to ensure compliance with data integrity standards.
• Prepare for and participate in regulatory inspections and audits concerning Data Integrity readiness.
• Compile and analyze reports and metrics related to data integrity, including the Data Integrity Maturity Model (DIMM), for management review.
• Act as the site representative in global data integrity forums, communicating relevant updates locally.

Qualifications and Experience

• A Bachelor’s degree in Science, Engineering, Pharmacy, Quality Assurance, or a related field is required.
• Minimum of five years experience within GMP-regulated environments in pharmaceutical, biotech, or medical device manufacturing.
• Deep knowledge of Data Integrity principles like ALCOA+ and familiarity with GxP guidelines.
• Proven background in supporting regulatory inspections and managing internal and external audits.
• Expertise in computerized system validation (CSV) and electronic quality systems.
• Experience leading investigations, performing risk assessments, and managing CAPA.
• Strong communication skills capable of influencing diverse, cross-functional teams.
• Capability to develop and deliver training on quality assurance or data integrity topics.
• Demonstrated analytical and problem-solving skills paired with a continuous improvement focus.
• Ability to juggle multiple priorities effectively, working both independently and collaboratively.

Additional Information

• Key roles include establishing site data integrity objectives, driving remedial actions from audit findings, and acting as a focal point between site and global forums.