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