QA Digital Compliance Manager
Core
Ensuring digital systems, records, and data handling in pharmaceutical operations adhere to regulatory standards like FDA 21 CFR Part 11 and EU Annex 11.
Role type
Manager, Digital Compliance
Builds
Compliant digital strategies and validated computerized systems lifecycle
Domain
Pharmaceutical industry, Regulatory Compliance, Digital Systems
Deliverable
client delivery
Required skills
Knowledge of FDA 21 CFR Part 11 and EU Annex 11, Data integrity and traceability oversight, Cybersecurity measures implementation, Validation document review, Change management, Risk assessments, Supplier qualification, Audit trail reviews
Preferred skills
Master's degree in Life Sciences or IT, Experience in managerial roles in complex organizations
Technologies
Manufacturing execution systems, Laboratory information management systems (LIMS), Electronic lab notebooks (ELN/LES), Instrument software
Responsibilities
Monitoring adherence to regulatory bodies (FDA, EMA), Updating knowledge on evolving digital compliance regulations, Maintaining quality oversight of data integrity, Supporting cybersecurity measures, Training employees on digital compliance, Auditing digital systems, Investigating non-compliance events, Collaborating with IT and other functions to maintain compliant strategies
Seniority
Manager, hands-on leadership
