QMS Implementation Lead - GMP Pharma (Scotland, 12m)

QMS Implementation Project Lead - Scotland - 12 months
Our client, a global pharmaceutical manufacturing organisation, are seeking a QMS Implementation Project Lead.
The client is a leader in its field supporting from early development through clinical and commercial production. With multiple facilities the client combines advanced scientific expertise with a quality-driven mindset collaborative partnerships and patient-focused approach to support the development and delivery of transformative therapies.
Responsibilities

• Lead the end to end implementation and deployment of a new Quality Management System (QMS) within a regulated manufacturing environment.
• Establish project governance, manage project plans, budgets, timelines, risks, and stakeholder communications.
• Coordinate cross functional teams across Quality, Manufacturing, QC, Validation, IT, Regulatory Affairs, and Operations.
• Work closely with external software vendors and implementation partners to ensure successful system delivery and adoption.
• Drive change management activities, training programmes, system go live, and post implementation continuous improvement initiatives.
  

• Proven experience leading a full QMS or eQMS implementation project as the client side Project Lead or Programme Manager.
• Strong background working within GMP regulated industries such as Pharmaceuticals, Biotechnology, Cell & Gene Therapy, or Food Manufacturing.
• Experience implementing platforms such as ACE, Veeva Vault Quality, MasterControl, TrackWise Digital, ETQ Reliance, or ComplianceQuest.
• Demonstrated ability to manage complex stakeholder groups and deliver large scale business transformation programmes.
• Knowledge of quality systems, computer system validation, compliance requirements, and regulated software deployments.