AbbVie is seeking a dynamic QA Systems Digital Lead to spearhead our QC Digital and Lab of the Future programs in Manorhamilton Road, Sligo. This role is crucial in aligning digital initiatives with QA objectives and enhancing lab automation and compliance efforts. As a pivotal member of our team, you will manage key projects, ensure systems stay updated and compliant, and drive continuous improvement in our quality assurance processes.
Key Responsibilities:
* Oversee the QA IT group's activities, including management of LIMS, SAP, Empower, and lab connectivity.
* Lead digital laboratory initiatives such as Lean Digital Lab, Lab of the Future, and Smart QC.
* Optimize quality control systems for greater efficiency and ensure data integrity across all systems.
* Implement and manage site-specific QC digital programs in line with organizational goals.
* Provide leadership in QC laboratory technology, collaborating with BTS Lab Engineer functions for timely installations and upgrades.
* Conduct thorough investigations of non-compliance issues, establishing effective corrective and preventive measures.
* Act as the primary point of contact for projects, ensuring seamless execution from initiation to completion.
* Maintain strong relationships with internal and external stakeholders to support quality and regulatory compliance.
* Lead team efforts in regulatory inspections and corporate audits, demonstrating ownership and expertise.
Qualifications:
* Bachelor’s Degree in Science or IT Discipline.
* Minimum of 5 years of experience in a pharmaceutical setting with IT or QC focus.
* Expertise in laboratory systems including LIMS, SAP, and Empower is advantageous.
* Strong attention to detail, with a proven track record of right-first-time outcomes.
* Excellent problem-solving skills and adaptability to new requirements.
* Demonstrated leadership in managing teams, setting annual goals, and improving team performance.
* Comprehensive understanding of GMP requirements and regulatory standards.
* Superior communication skills, both verbal and written, paired with strong interpersonal abilities.
This role offers an exciting opportunity to lead groundbreaking digital transformation initiatives within our QA organisation. If you are a strategic thinker with a drive for excellence and innovation, apply now to join AbbVie's talented team!
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