Project Lead - QA Systems (eDMS)

Job Title

Quality Systems Manager

Description

Lead the implementation and rollout of an electronic Document Management System (eDMS) within a GMP-regulated environment. The role focuses on quality systems, GxP document management, system implementation, process harmonisation, and stakeholder coordination across multiple countries.

Sectors: Life Sciences – Pharmaceuticals, Biotechnology, Healthcare.

Company Size & Type: Global Healthcare Organisation.

Non‑Negotiable Requirements

• Experience in Quality Management within a GMP, GDP, or GxP-regulated environment
• Experience implementing or rolling out an electronic Document Management System (eDMS) or electronic Quality Management System (eQMS)
• Experience managing or leading cross‑functional projects
• Experience with GxP document management processes
• Experience developing Business Requirement Specifications (BRS) or system requirements documentation
• Experience supporting User Acceptance Testing (UAT)
• Fluent German and English language skills

Desirable Requirements

• Experience within pharmaceutical, biotechnology, healthcare, or medical device industries
• Experience with quality systems implementation projects
• Experience with document migration projects
• Experience with Veeva, MasterControl, TrackWise, Documentum, or similar quality systems
• Experience supporting GxP computer system validation activities
• Knowledge of GMP, GDP, and GxP regulations
• Experience delivering training materials and end‑user adoption programmes
• Experience working in international or multi‑country environments
• Experience with digital quality transformation initiatives

Responsibilities

• Analyse and harmonise GxP document management processes across multiple regions and business units
• Define and execute eDMS migration and rollout activities
• Lead implementation activities and coordinate deployment plans with regional stakeholders
• Develop and maintain Business Requirement Specifications (BRS)
• Review system design, validation, testing, and implementation documentation
• Coordinate and support User Acceptance Testing (UAT) activities
• Collaborate with Quality, IT, and Business stakeholders throughout the project lifecycle
• Support training development, process harmonisation, and system adoption activities
• Ensure compliance with GMP, GDP, GxP, and internal quality standards
• Act as a key contact for Quality Systems implementation activities across the organisation