QMS Implementation Project Lead

QCS Staffing; Scotland; On-site; GBP 75,000 - 95,000; Full time

Job summary

QMS Implementation Project Lead in Scotland is sought by our client to drive end-to-end QMS deployment in a regulated manufacturing environment, coordinating across Quality, Manufacturing, IT and Regulatory Affairs.

You will manage governance, plans and budgets, work with vendors, and deliver training, go-live and post-implementation improvements. This is a 12-month assignment requiring proven leadership in GMP settings and strong stakeholder management.

Qualifications

• Experience leading a full QMS/eQMS implementation project.
• Background in GMP-regulated industries (pharma/biotech/food).
• Experience implementing platforms such as ACE, Veeva Vault Quality, MasterControl, TrackWise Digital, ETQ Reliance, or ComplianceQuest.
• Ability to manage diverse stakeholders and deliver large-scale transformation programmes.
• Knowledge of quality systems, computer system validation, compliance requirements, and regulated software deployments.

Responsibilities

• Lead end-to-end implementation of a QMS within a regulated manufacturing environment.
• Establish governance, manage plans, budgets, timelines, risks, and stakeholder communications.
• Coordinate cross-functional teams across Quality, Manufacturing, QC, Validation, IT, Regulatory Affairs, and Operations.
• Work with external vendors/partners to ensure delivery and adoption of the system.
• Drive change management, training, go-live, and post-implementation improvements.

Skills

QMS implementation

GMP experience

Stakeholder management

Cross-functional leadership

Quality systems

Tools

ACE

Veeva Vault Quality

MasterControl

TrackWise Digital

ETQ Reliance

ComplianceQuest

Job description

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.

Requirements

• 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.