QA Digital Compliance Manager

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.
• 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.
• Bachelor's degree in Life Sciences, IT or related field; master's degree preferred.
• 5/10+ years of experience in digital compliance applied in 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.
• AbbVie 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.
• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
• https://www.abbvie.com/join-us/reasonable-accommodations.html

Additional Information

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.

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