Company Description
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, and products and services in our Allergan Aesthetics portfolio.
About AbbVie
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, and products and services in our Allergan Aesthetics portfolio.
Job Description
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. 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 computerized systems lifecycle such as manufacturing execution system, and 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.
* Supporting as subject‑matter expert the training of employees and stakeholders on digital compliance requirements and best practices and of the audit of digital systems and assurance of adherence to GMP, company policies and other relevant standards, including risk assessments, supplier qualification and periodic system audit trail reviews.
* 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.
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 in English.
* 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. Equal Opportunity Employer/Veterans/Disabled.
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