Not specified (assumed to be onsite based on location)
8 to 15 years pharmaceutical industry experience
Expert knowledge of 21 cfr part 11 and eudralex
Subject matter expertise in data integrity principles
Roche is seeking a Data Integrity Lead in Basel, Switzerland, who will play a critical role within the Network Quality Assurance Team, focusing on data integrity challenges and compliance across the organization. The ideal candidate will have extensive experience in the pharmaceutical industry, particularly in data integrity principles, and will contribute to maintaining high standards of regulatory compliance
Job Summary
This role serves as a key member of the Network Quality Assurance Team, acting as the primary subject matter expert for complex data integrity challenges.
The successful candidate will represent the organization during internal and external regulatory inspections regarding data integrity and manage remediation efforts using QRM principles.
Roche fosters a culture of personal expression and open dialogue where every voice matters, aiming to prevent, stop, and cure diseases globally.
Matching Summary
Match Score: 85
Roche is seeking a Data Integrity Lead in Basel, Switzerland, who will play a critical role within the Network Quality Assurance Team, focusing on data integrity challenges and compliance across the organization. The ideal candidate will have extensive experience in the pharmaceutical industry, particularly in data integrity principles, and will contribute to maintaining high standards of regulatory compliance.
Skills & Requirements
Must-have
8 to 15 years pharmaceutical industry experience
Expert knowledge of 21 CFR Part 11 and EudraLex
Subject matter expertise in Data Integrity principles
Experience with computerized systems validation
Proficiency in Quality Risk Management (QRM)
Nice-to-have
Strong project management and change management skills
Ability to influence cross-functional teams
Fluency in English and German languages
Experience leading training efforts for SMEs
Key Requirements
Bachelor's or Master's degree in Life Sciences, Engineering, or Computer Sciences
8 to 15 years relevant pharmaceutical or biologics industry experience
Expert knowledge of US and EU regulatory requirements including ICH Guidelines