Data Integrity Program Lead

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Job Summary

NOTE: This position will sit On-Site in Memphis, TN

The Site Data Integrity (DI) Program Lead is responsible for ensuring the site operates under applicable regulatory policies and Charles River Laboratories corporate policies for documentation and data integrity to ensure consistency and continuity across all functional segments at the Charles River Laboratories Memphis site. The Data Integrity Program Lead is the site data integrity Subject Matter Expert and will be responsible to ensure adequate SOPs, processes and training and education for Data Integrity principles are in place and consistently implemented at the Memphis site for cGxP data, both in paper and/or electronic format. The Site DI Program Lead must exhibit ability to develop and sustain collaborative partnerships across all functions at the Memphis site to implement, mature, and sustain delivery to DI principles and requirements for all paper and electronic data.

• The Site DI Program Lead is the point person during regulatory inspections and internal and client audits for Data integrity and plays a major role to answer questions and demonstrate that necessary controls and required competencies are in place with respect to Data Integrity
• Ensures all new equipment and instrumentation is assessed appropriately and validated for its intended use and lifecycle management of data storage, review, and archival.
• Facilitate holistic data integrity reviews by partnering with cross-functional groups and stakeholders to conduct end to end business process assessments. Communicates actions, compliance gaps, and commitments to respective areas including the Site Director of Quality and reports on health of the DI Program at Memphis at monthly Quality Management Review governance meetings.
• Assist in sourcing, assessing, and recommending instrumentation and equipment for purchase; meets with vendors to discuss software capabilities with respect to 21CFR Part 11 compliance
• Provides periodic training to all operations to ensure awareness and compliance with data integrity for both paper and electronic records, including inspector interaction and good documentation practices
• Creates and updates procedures and processes as necessary to ensure operation’s awareness of the importance of regulatory requirements and expectations
• Routinely evaluates regulatory inspection documents and updates site procedures accordingly
• Aids in establishing user requirements for equipment
• Establishes and leads a data integrity program and partners with internal auditing teams to ensure internal audits at the site are assessed for compliance to documentation and data integrity standards, practices, and procedures.
• Perform all other related duties as assigned

Job Qualifications

• Bachelor’s degree in a science related field preferred
• Minimum 7 years’ experience in a regulated industry, or 5 years with related technical knowledge including data integrity related to quality control, knowledge of laboratory instrumentation and/or operations equipment and associated computer systems
• Advanced knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
• Thorough understanding of data integrity review, 21CFR Part 11 requirements, instrumentation compliance
• Strong technical knowledge and experience writing and reviewing investigations within a Quality Management System (TrackWise, preferred)
• Experience must include proven knowledge of Data Integrity (DI) related risk assessments and identification of mitigation actions
• Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)
• Effective written, interpersonal, and presentation skills
• Ability to work on multiple projects simultaneously

The pay range for this position is $111,700 - $124,900. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.