QA Digital Compliance Manager

ph3Job Description /h3 pThe 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. /p h3Key Responsibilities /h3 ul liMonitoring 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, and keeping updated with evolving digital compliance regulations and trends (e.g. Annex 22 about AI). /li liEnsuring and maintaining quality oversight of data integrity and traceability across the lifecycle of computerized systems such as manufacturing execution systems, laboratory information management systems (LIMS), electronic lab notebooks (ELN/LES), and instrument software. /li liSupporting the implementation of proper cybersecurity measures to protect data and prevent unauthorized access or tampering. /li liServing as a subject‑matter expert for training employees and stakeholders on digital compliance requirements and best practices, and for auditing digital systems to ensure adherence to GMP, company policies and other relevant standards, including risk assessments, supplier qualification and periodic system audit‑trail reviews. /li liEnsuring that software and digital tools used in operations are validated and documented according to regulatory and company requirements through the review and approval of validation documents. /li liSupporting the development, review and update of digital compliance policies and procedures. /li liCollaborating with global and local IT, BTS and all relevant functions to maintain compliant digital strategies. /li liInvestigating and responding to non‑compliance events and contributing to change management and lifecycle handling. /li /ul h3Qualifications /h3 ul liBachelor's degree in Life Sciences, IT or related field; master’s degree preferred. /li li5–10+ years of experience in digital compliance applied in the pharmaceutical industry. /li liStrong knowledge of pharmaceutical regulations (FDA, EMA, etc.). /li liExcellent communication and training skills. /li liFluent English language. /li liAnalytical mindset and attention to detail. /li liExperience in managerial roles in complex organizations. /li /ul h3Additional Information /h3 pAbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. /p pUS Puerto Rico only – to learn more, visit /p pUS Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: /p /p #J-18808-Ljbffr