The QA Digital Compliance Manager is responsible for ensuring that all digital systems, records, instruments, processes and data handling within operations adhere to relevant regulatory, legal, best practices and industry standards.
Key Responsibilities:
- Monitoring and ensuring adherence to relevant regulatory bodies (e.g. FDA, EMA) for digital content and initiatives in compliance with regulations like FDA 21 CFR Part 11 and EU Annex 11. Keeping updating with evolving digital compliance regulations and trends (eg Annex 22 about AI).
- Ensuring and maintaining Quality oversight of data integrity and traceability across computerized systems lifecycle such as manufacturing execution system, and laboratory information management systems (LIMS), electronic lab notebooks (ELN/LES), and instrument software.
- Support the implementation of proper cybersecurity measures to protect data and prevent unauthorized access or tampering.
- Supporting as Subject Matter Expert the training to employees and stakeholders on digital compliance requirements and best practices and the audit of digital systems and assure the adherence to GMP, company policies and other relevant standards, including risk assessments, Supplier qualification and periodic System Audit Trail reviews.
- Ensuring software and digital tools and systems used in operations are validated and documented according to regulatory and company requirements through the review and approval of validation documents
- Supporting the development, review, and update of digital compliance policies and procedures.
- Collaborating with Global and Local IT, BTS and all relevant functions to maintain compliant digital strategies.
- Investigating and responding to non-compliance events. Contributing to change management and lifecycle handling.