03 set - Roma
Altro
Le interessa questa occasione? Si candidi in fretta, è previsto un elevato volume di candidature. Scorra verso il basso per leggere la descrizione completa. 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, and keeping updated with evolving digital compliance regulations and trends (e.g. Annex 22 about AI).
Ensuring 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. Supporting the implementation of proper cybersecurity measures to protect data and prevent unauthorized access or tampering. Serving 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.
Ensuring 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. 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 and contributing to change management and lifecycle handling.
Qualifications Bachelor's degree in Life Sciences, IT or related field; master's degree preferred. 5-10+ years of experience in digital compliance applied in the pharmaceutical industry. Strong knowledge of pharmaceutical regulations (FDA, EMA, etc.). Excellent communication and training skills.
Fluent
English language. Analytical mindset and attention to detail.
Experience in managerial roles in complex organizations.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. xrdztoy Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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