Assoc Dir - Computer System Quality Assurance & Site Data Lead

Negotiable
  1. Permanent
Shannon, Republic of Ireland
  1. Quality Assurance, Quality Systems
Posted: 14/07/2025
BBBH27695

Help bring science to life and join a leading pharmaceutical company to play a key role in delivering impactful research that drives healthcare innovation!

Hobson Prior is seeking an AD for Computer Systems Quality Assurance (CSQA) and Data Integrity to join a cutting-edge biopharmaceutical manufacturing facility. In this role, you will ensure the standards, regulatory adherence, and reliability of digital systems supporting production, lab, and storage functions. You will also lead efforts in data governance, system validation, and inspection readiness while fostering a culture of continuous improvement and compliance.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

  • Implement and maintain quality standards for electronic systems and data management.
  • Oversee validation and compliance of computerized systems, including manufacturing and laboratory platforms.
  • Conduct inspections and assessments to ensure adherence to regulatory requirements.
  • Manage system change controls, deviations, and corrective actions.
  • Develop frameworks to ensure data quality and integrity across all processes.
  • Provide oversight for systems such as MES, DeltaV, LIMS, ELN, and SAP.
  • Support automation initiatives and system integration projects.
  • Prepare for and participate in regulatory inspections and audits.
  • Train and mentor team members on data integrity and compliance practices.

Key Skills and Requirements:

  • Background in science, engineering, computer science, or a related field.
  • Knowledge of regulatory standards (e.g., FDA, EMA, GAMP 5) and data integrity principles.
  • Experience with laboratory systems (e.g., LIMS, CDS, ELN) and enterprise platforms (e.g., SAP, MES).
  • Strong leadership, communication, and decision-making skills.
  • Familiarity with system validation processes, including risk-based approaches.

For more information, please contact Billy O'Brien.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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