QA Digital Compliance Manager

Responsibilities

• Monitor and ensure adherence to regulatory bodies (e.g., FDA, EMA) for digital content, including compliance with FDA 21 CFR Part 11 and EU Annex 11.
• Maintain quality oversight of data integrity and traceability across computerized system lifecycles, such as LIMS, MES, and electronic lab notebooks.
• Support the implementation of cybersecurity measures to protect data and prevent unauthorized access.
• Act as a Subject Matter Expert (SME) to provide training to employees and stakeholders on digital compliance and best practices.
• Conduct audits of digital systems to ensure adherence to GMP, company policies, and other relevant standards.
• Review and approve validation documents to ensure software and digital tools are properly documented.
• Collaborate with Global and Local IT and other relevant functions to maintain compliant digital strategies.
• Investigate and respond to non-compliance events and contribute to change management processes.

Requirements

• Bachelor’s degree in Life Sciences, IT, or a related field (Master’s degree preferred).
• 5-10+ years of experience in digital compliance within the pharmaceutical industry.
• Strong knowledge of pharmaceutical regulations, including FDA and EMA.
• Excellent communication and training skills.
• Fluency in English.
• Analytical mindset with high attention to detail.
• Experience in managerial roles within complex organizations.

About the Company

AbbVie'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.