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Project lead - qa systems (edms) (m/w/d)

Taufkirchen
Real Staffing
Inserat online seit: 26 Mai
Beschreibung

A global, innovation‑driven healthcare organisation is advancing digital transformation across highly regulated environments. With a strong international footprint and a long‑standing commitment to quality, compliance, and patient impact, the organisation offers senior professionals the opportunity to lead complex, cross‑regional initiatives with real influence.


Your mission

As Project Lead QA for an electronic Document Management System (eDMS), you will lead the EUCAN rollout (Europe & Canada) of a global, quality‑critical system. Positioned at the intersection of quality, compliance, and digitalisation, this role requires strong leadership across countries, cultures, and regulatory frameworks.
You will be responsible for harmonising GxP document management processes and ensuring the successful adoption of the system across the region.


Key responsibilities

* Analyse and harmonise GxP document management processes across the EUCAN region
* Define and execute the regional migration and rollout strategy for a global eDMS
* Lead the end‑to‑end implementation across multiple countries
* Develop and issue Business Requirement Specifications (BRS) aligned with regulatory needs
* Review design, validation, and test documentation to ensure compliance
* Lead and coordinate User Acceptance Testing (UAT) with regional stakeholders
* Partner with Process Leads to design and deliver training concepts and materials
* Act as a key interface between Quality, IT, and Business teams across EUCAN


Your profile

* 5+ years' experience in Quality Management within a regulated pharmaceutical or life‑sciences environment
* Proven experience delivering eDMS or quality system implementations
* Strong project leadership experience in multi‑country settings
* Solid knowledge of GMP/GDP and GxP documentation requirements
* High affinity for electronic systems and digital quality processes
* Excellent analytical and communication skills
* Fluent in German and English
* Comfortable operating in international, cross‑functional EUCAN environments


Why this opportunity

* High‑visibility role with regional EUCAN impact
* Hybrid working model with flexibility
* Locations: Munich or Pfaffenhofen
* Long‑term growth and development potential
* Direct contribution to compliance, quality, and patient safety

SThree_Germany is acting as an Employment Agency in relation to this vacancy.

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