To drive excellence in the implementation and maintenance of QC information systems with a strong focus on digital transformation. This role supports the vision to develop a state-of-the-art digital laboratory, encouraging AI and modern digital integration to enhance lab throughput and compliance.

The Specialist will oversee and optimize key QC platforms (LIMS, SAP, Empower, SmartQC), and actively contribute to continuous improvement, and lead technology adoption within the lab.

Role & Responsibilities:

• Ensure all QC Information and Computerized Systems are fully compliant with Data Integrity and cGMP regulations, and that platforms are kept up-to-date and fit for purpose.

• Act as QC Department lead for and demonstrate strong working knowledge of laboratory systems including LIMS and SAP; familiarity with Chromatography Data Systems (CDS) such as Empower an advantage.

• Liaison point of contact for Global Abbvie Support for LIMS, SAP, Empower and SmartQC (lab planning tool).

• Support and guide the introduction, validation (CSV), and integration of new digital solutions and technologies—including AI-driven applications.

• Build excellent interpersonal relationships across teams and act as a key point of contact for both internal and external stakeholders.

• Optimize QC workflows by leveraging digital tools and automating processes using LIMS, SAP, and other software

• Train and mentor employees on relevant systems, digital best practices, and data integrity requirements.

• Collaborate with cross-functional teams including BTS Lab Engineers, global QC and IT teams, contractors, and consultants for successful technology projects.

• Maintain precise, complete records of work performed, with a focus on digital documentation and data integrity.

• Uphold all safety aspects of the role and contribute to lab compliance culture.

• Subject Matter Expert in regulatory inspections and audits.

• Drive continuous improvement, identifying and implementing enhancements to QC systems and digital processes.

• Actively contribute to the lab's digital transformation journey, championing AI, automation, and integration initiatives.

• Relevant third-level degree and/or industry certification.

• Proficient in cGMP work practices and digital system integration.

• Minimum 3 years’ experience in a pharmaceutical QC or IT environment.

• Strong practical knowledge of LIMS, SAP, and QC-related digital platforms (Compliance Wire, EDMS, SmartQC).

• Experience with Chromatography Data Systems (Empower) highly desirable.

• Experience with the administration of digital training platforms such as Compliance Wire would be an advantage.

• Track record of driving or supporting digital transformation, technology adoption, or continuous improvement initiatives.

• Project management skills; experience working in cross-functional teams.

• “Train the Trainer” and onboarding of new digital tools and best practices.

Abb Vie 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

About Abb Vie

Abb Vie'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 Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.