QC Systems & Digital Transformation Specialist

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 technologiesincluding 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 labs digital transformation journey championing AI automation and integration initiatives.

Qualifications :

• 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.

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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time