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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job DescriptionThe 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 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.
- Supporting 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.
- 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
Skills Required
- Bachelor's degree in Life Sciences, IT, or related field
- Master's degree
- 5+ years of experience in digital compliance applied in the pharmaceutical industry
- Experience with MES, LIMS, ELN/LES and instrument software lifecycle management
- Knowledge of FDA 21 CFR Part 11 and EU Annex 11 (and evolving regulations such as Annex 22)
- Experience in computerized system validation and review/approval of validation documents
- Experience supporting cybersecurity measures for digital systems and data protection
- Experience conducting audits, system audit trail reviews, supplier qualification, and risk assessments
- Excellent communication and training skills
- Fluent English
- Analytical mindset and strong attention to detail
- Experience in managerial roles within complex organizations
AbbVie Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.
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Retirement Support — Retirement programs are portrayed as a standout, with a dollar‑for‑dollar 401(k) match up to 6% and an additional annual company contribution based on age and service. Feedback suggests this materially boosts perceived total compensation for many U.S. employees.
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Parental & Family Support — Paid parental and caregiver leave are emphasized, including up to 12 weeks of fully paid parental leave for all parents and 4 weeks of paid caregiver leave in the U.S. Feedback suggests these policies are a meaningful differentiator for employees balancing family needs.
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Leave & Time Off Breadth — Time off is described as extensive, with tiered vacation that scales with tenure, 17 company holidays, and two paid volunteer days in the U.S. Feedback suggests the breadth of leave contributes notably to overall benefits satisfaction.
AbbVie Insights
What We Do
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.
