Ph3Company Description /h3 pbAbout AbbVie /b /p pAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube. /p h3Job 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. Keeping updating with evolving digital compliance regulations and trends (eg Annex 22 about AI). /li liEnsuring 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. /li liSupport the implementation of proper cybersecurity measures to protect data and prevent unauthorized access or tampering. /li liSupporting 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. /li liEnsuring 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 /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. 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 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 h3What AbbVie Has to Offer /h3 pOur work can—and does—have a tangible, lasting impact on millions of people. But it’s not just the results that matter. How we achieve them matters, too. Leading with purpose, we work to build a more sustainable future for generations to come. We do that by putting our expertise, resources and talent to work to make a real difference for patients, communities and our world. /p /p #J-18808-Ljbffr