Data Integrity Lead

Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat - heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt. Die Position

As the Data Integrity Lead, you will be a key member of the Network Quality Assurance Team, serving as the Quality Assurance subject matter expert (SME) and a critical individual contributor focused on complex Data Integrity challenges, deviations, and remediation efforts across the network. Your expertise will be essential in applying advanced technical principles and expert judgment to address a diverse array of challenges related to GxP compliance and computerized systems, while promoting network-wide alignment and driving continuous improvement of compliance practices.

In this leadership role, you will oversee GxP data integrity initiatives, collaborating closely with both site-specific teams and network-wide stakeholders to maintain the highest regulatory compliance standards. Acting as the bridge between technical data management and quality assurance, you will ensure the protection and optimization of the end-to-end product lifecycle.

The Network Quality Assurance Team is dedicated to fostering robust quality frameworks and establishing effective oversight mechanisms. As part of this team, you will contribute to driving continuous improvement, ensuring compliance with quality standards, and enabling efficient decision-making through technical leadership, advanced analytics, and seamless collaboration across various Quality functions.

The Opportunity

As you join our team, you will have the chance to drive excellence in data compliance through the following responsibilities:

• Serve as the network-wide technical SME for Data Integrity principles and computerized systems, providing expert judgment and independent resolution for complex technical issues.
• Manage and direct remediation efforts using Quality Risk Management (QRM) principles to identify risks, establish priorities, and assess technical responses to compliance questions.
• Represent the organization as the primary Quality Assurance SME during internal and external regulatory inspections regarding data integrity.
• Act as the Quality Process Owner (QPO) for Data Integrity, overseeing DI Maturity Assessments and collaborating with PT Data Compliance to develop monitoring metrics and trending reports (e.g., MROQ).
• Partner with Site DI Stewards and the Quality Digital Data Compliance Lead to support digital GxP data governance, mitigate risks, and ensure all GMP records and systems are assessed appropriately.
• Collaborate with PTQ Coremap, Information Compliance SPOCs, and data governance representatives to align site initiatives and maintain best-in-class practices.
• Develop comprehensive training materials and lead training efforts for SMEs and relevant stakeholders to ensure data integrity assurance across all functional areas.

Do you have experience in Quality assurance?, Do you have a Master's degree?, We are looking for a dedicated professional who meets the following criteria:

• Possesses a Bachelor's or Master's degree in Life Sciences, Engineering, Computer Sciences, or a related field with at least 8 to 15 years of relevant pharmaceutical or biologics industry experience.
• Demonstrates subject matter expertise in Data Integrity principles, system validation, and computerized systems, including proficiency in electronic document management and laboratory information systems.
• Maintains expert knowledge of US and EU regulatory requirements, including 21 CFR Part 11, EudraLex Volume 4 (Part I, II, and Annex 11), and ICH Quality Guidelines.
• Exhibits strong project management and change management skills, with a proven ability to motivate and influence diverse, cross-functional teams of SMEs at all levels of the organization.
• Is a proficient communicator in English (and German as per template requirements) with the ability to provide clear technical guidance and training to stakeholders across various sites.

Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!