Beschreibung

In this role, you will tackle complex Data Integrity challenges while ensuring compliance with GxP standards. Your day-to-day responsibilities will involve collaborating with various teams, managing remediation efforts, and leading training initiatives to uphold data integrity across the network.

Anforderungen

• •Bachelor’s or Master’s degree in Life Sciences, Engineering, Computer Sciences, or related field
• •8 to 15 years of relevant pharmaceutical or biologics industry experience
• •Subject matter expertise in Data Integrity principles, system validation, and computerized systems
• •Proficiency in electronic document management and laboratory information systems
• •Expert knowledge of US and EU regulatory requirements, including 21 CFR Part 11 and ICH Quality Guidelines
• •Strong project management and change management skills
• •Ability to motivate and influence diverse, cross-functional teams
• •Proficient communicator in English and German
• •Ability to provide clear technical guidance and training to stakeholders

Aufgaben

• •Serve as the technical SME for Data Integrity principles
• •Provide expert judgment for complex technical issues
• •Manage remediation efforts using Quality Risk Management principles
• •Identify risks and establish priorities for compliance questions
• •Represent the organization during regulatory inspections
• •Act as the Quality Process Owner for Data Integrity
• •Oversee DI Maturity Assessments and develop monitoring metrics
• •Collaborate with Site DI Stewards to support digital GxP data governance
• •Mitigate risks and assess GMP records and systems
• •Align site initiatives with PTQ Coremap and data governance representatives
• •Develop training materials for SMEs and stakeholders
• •Lead training efforts to ensure data integrity assurance