IT Product Manager, Quality Systems

Harry Walsh Associates Recruitment; Cork; On-site; EUR 50,000 - 70,000; Full time

Job summary

A leading recruitment agency is seeking an IT Business Analyst for a global pharmaceutical manufacturer. This role involves managing upgrades to IT systems, focusing on Quality and Supply Chain in a regulated environment. The successful candidate will have at least a Bachelor's in a STEM field and experience with Quality platforms. You'll be pivotal in maximizing automation efficiency in a high-volume manufacturing setup.

Qualifications

• Proven experience in managing stakeholders and navigating complex environments.
• Deep understanding of current IT digitisation, cloud, and cyber security.
• Technical experience with Quality platforms required.

Responsibilities

• Lead remediation and upgrade projects on legacy systems.
• Manage projects across QA, QC, and Supply Chain functions.
• Oversee migrations and application risk analysis.

Skills

Stakeholder management

Understanding of digitisation

Project management in QA/QC

Technical analysis

Knowledge of GxP regulations

Education

Bachelor's Degree in Computer Science or STEM

Tools

LIMS systems

Chromatography systems (Chromeleon, Empower)

Quality Management Systems

Job description

Our client, a leading global pharmaceutical manufacturer, requires an IT Business Analyst who has led upgrades to IT systems, specifically for Quality and Supply Chain departments in a regulated environment.

Responsibilities

• Proven experience in managing stakeholders and demonstrating the ability to navigate a complex business environment.
• Deep understanding of the current and developing IT arena, specifically digitisation, cloud, and cyber security.
• Lead remediation and upgrade projects on legacy systems to align with current technologies.
• Manage projects across QA, QC, Production Quality Systems, and Supply Chain functions.
• Oversee migrations, new technology introductions, cyber risks, and application risk analysis.
• Collaborate with and be supported by other organizational teams, including the IT Architecture Team, Cyber Security, and Technical Support.

Experience

• Bachelor's Degree in Computer Science, STEM majors, or equivalent.
• Relevant professional experience in the Pharma or IT industry, including the Digital Lab domain.
• Technical experience with Quality platforms such as LIMS, Chromatography systems (Chromeleon, Empower), Environmental Monitoring, and Quality Management Systems.
• Expertise in analysis, design, and system architecture concepts.
• Thorough knowledge of CSV lifecycle and GxP regulations (GLP, GCP, GMP), 21CFR Part 11, EU Annex 11.
• Ability to operate in a technical environment and understand technical solutions and challenges.
• Understanding of lab business processes; drug development experience is advantageous.
• Ability to analyze problems and develop requirements in an agile manner.

This opportunity allows you to join a well-established international high-volume manufacturing facility. The primary purpose of this role is to maximize the efficiency of automation and control devices in manufacturing, packaging, and molding processes, while maintaining operational standards.