QMS Consultant

Walker Cole International is supporting an Ireland-based biotechnology organisation in the appointment of a QMS Consultant to support the implementation of a new electronic Quality Management System (eQMS). This role will provide expert guidance in developing, digitising and optimising quality processes while ensuring compliance with global GxP and regulatory requirements.

This position will play a critical role in transforming and strengthening the organisation’s Quality Management System, ensuring the successful rollout, adoption and continuous improvement of the new eQMS platform across the business.

Key Responsibilities

• Lead and support the implementation and rollout of a new eQMS
• Assess the current Quality Management System and identify gaps, improvements and digitisation opportunities
• Ensure the eQMS is aligned with GxP, EU GMP and global regulatory expectations
• Support the configuration, validation and deployment of the eQMS platform
• Develop and optimise core QMS processes within the new system, including:
  • Deviations
  • CAPA
  • Change control
  • Document management
  • Training management
  • Supplier management
  • Audits and inspections
• Support CSV/CSA activities related to the eQMS implementation
• Provide guidance on QMS governance, workflows and best practice
• Collaborate with Quality, IT, Regulatory Affairs and Operations to ensure successful implementation and adoption
• Deliver training and change management support to ensure effective system use across the organisation
• Ensure the organisation maintains a strong state of inspection readiness
• Support continuous improvement and long-term QMS strategy

Required Experience and Skills

• Proven experience as a QMS Consultant within the biotech, pharmaceutical or life sciences sector
• Demonstrable experience implementing or remediating eQMS platforms
• Strong working knowledge of EU GMP and wider GxP regulations
• Experience supporting CSV/CSA and system validation
• Strong expertise in QMS processes including deviations, CAPA, change control, document control and training systems
• Experience supporting regulatory inspections and audit readiness
• Strong stakeholder engagement and change management skills
• Ability to operate effectively in a hands-on contract role
• Experience working with biotech or biologics organisations (desirable)

Working Pattern

On-site (Ireland)

Contract Length

6 months

Rate

Day rate negotiable depending on experience

Location

Ireland

Keywords

QMS Consultant | eQMS | GMP | Biotech | CSV | CSA | CAPA | Deviations | Change Control | Contract | Regulatory Compliance