Roche is seeking a Data Integrity & Quality Governance Lead to support data integrity related programs, ensuring compliance with regulations and advancing scientific innovation for a healthier future.
Requirements
- Knowledge of manufacturing data, QC data, computerized systems, GMP records and Veeva (QMS).
- Possess a thorough understanding and application of 21 CFR 211, 21 CFR Part 11, EudraLex Volume 4 Part I, II and Annex 11, ICH Quality Guidelines, MHRA and WHO Guidances on Data Integrity, and ISPE GAMP Guide - Records and Data Integrity
Responsibilities
- Responsible for the development and sustainment of the site data integrity assurance
- Provide quality oversight of the site data integrity program
- Collaborate with functional areas to have processes that evaluate data integrity elements, implement improvements and assure all GMP records, processes, equipment, and computerized systems are assessed appropriately and validated for the intended use, with respect to data integrity and compliance with cGMP requirements
- Serve as the site Data Integrity SME. Assess technical responses and provide decisions to questions/issues
- Interact with and lead Data Integrity initiatives in collaboration with site and network SMEs
- Provide guidance and training regarding data integrity assurance to relevant stakeholders
- Create/update procedures as necessary to ensure site awareness and importance of health authority requirements and expectations.
Other
- Serve as the Site representative on cross-functional and multi-site teams.
- Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
- Develop and train personnel and internal customers on relevant business processes.
- Collaborate and develop site policies and procedures.
- Experience successfully coordinating and navigating complex issues with internal and external stakeholders