THE POSITION

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

JOB RESPONSIBILITIES: GENERAL

• Follow company policies and procedures.
• Serve as the Site representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Develop and train personnel and internal customers on relevant business processes.
• Collaborate and develop site policies and procedures.
• Identify potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Approve documents for activities as authorized and described by Roche policies, procedures and job descriptions.
• Perform tasks as requested by Management to support quality oversight activities.
• Support internal and health authority inspections

JOB RESPONSIBILITIES: SPECIFIC

• 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
• Communicate actions, compliance gaps, and commitments to respective areas
• Create/update procedures as necessary to ensure site awareness and importance of health authority requirements and expectations. Routinely evaluate health authority inspection documents and keep the site aware of inspection trends
• Collaborate with the site Data Integrity Stewards and provide assessments and status updates to aid their actions to maintain and proactively improve data integrity
• Support the project execution of specific deliverables related to data integrity strategy
• Collaborate with internal and external data integrity experts
• Provide oversight and ownership for Quality Governance needs such as Quality Council and the Management Review of Quality Systems. Responsible for Quality Operations Metrics to identify trends and drive continuous improvement.
• Develop, generate, and report Quality System management metrics