Director, GTS Quality Systems

Scorpion Therapeutics; Deutschland; Remote; EUR 120.000 - 170.000; Vollzeit

Zusammenfassung

Scorpion Therapeutics seeks a Director of Quality Systems to lead global technology operations and deploy enterprise QMS platforms, primarily Veeva Quality applications, in a biopharma setting. The role ensures compliant, scalable Quality technology solutions aligned with GxP and data integrity standards.

You will lead GTS delivery, manage operations, coordinate vendor and project management, translate business needs into technical plans, support validation and CSA deliverables, and drive system

Qualifikationen

• Bachelor's degree in Engineering, CS, or related field with 7+ years in supporting Quality systems.
• Hands-on experience with Veeva Quality applications and GxP processes.
• Knowledge of 21 CFR Part 11, data integrity, validation, and CSA.

Aufgaben

• Lead GTS delivery and support for QMS systems.
• Manage application operations and vendor/project management.
• Translate business needs into technical plans.
• Support validation and CSA deliverables.
• Oversee enhancements across document control, deviations, CAPA, change control, and audits.
• Manage budgets, demand, and roadmaps; supervise a team of three.

Kenntnisse

Quality GxP

Data integrity

Validation

Ausbildung

Bachelor’s degree in Engineering/CS

Master’s degree in Engineering/CS

Tools

Veeva Quality

CSA tooling

Jobbeschreibung

Role

Director of Quality Systems, overseeing global technology operations and deployment of enterprise QMS platforms, primarily Veeva Quality applications, within a biopharma setting. Objectives include ensuring compliant, scalable Quality technology solutions aligned with GxP and data integrity standards.

Responsibilities

lead GTS delivery and support for QMS systems, manage application operations, coordinate vendor and project management, translate business needs into technical plans, support validation and CSA deliverables, and oversee system enhancements across Quality processes such as document control, deviations, CAPA, change control, and audits. Manage budgets, demand, and roadmaps; collaborate with Global Quality, site Quality, GTS teams, and vendors; and supervise a team of three.

Qualifications

bachelor’s degree in Engineering, Computer Science, or related field with 7+ years of experience (or master’s degree with 5+ years) in supporting Quality systems; hands‑on experience with Veeva Quality applications and Quality GxP processes; knowledge of 21 CFR Part 11, data integrity, validation, and CSA.

Preferred

experience with Validation Management Systems, Inspection Management, AI tools, and other regulated Quality systems.

Work setup

primarily remote with less than 20% domestic/international travel. Emphasis on cross‑functional collaboration, vendor management, and ensuring validated, compliant systems to support Quality business needs.