GMP Change & TrackWise Lead — Supply Chain QA (Hybrid)

Lonza; Oberwallis; Hybrid; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile career development

Inclusive workplace

Competitive hourly rate

Zusammenfassung

Lonza in Visp, Switzerland, seeks a GMP-focused QA/Supply Chain professional for a hybrid, fixed-term role. You will manage TrackWise change requests and concept changes, coordinate with QA, manufacturing, IT and engineering, and drive compliant, efficient drug manufacturing operations.

You will develop SOPs and work instructions, monitor change activities, and support audit readiness while enabling continuous improvement in a regulated environment. Fluency in English; German is a plus.

Qualifikationen

• GMP-regulated QA or supply chain background.
• Experience managing Change Requests, Concept Changes, Change Controls, Deviations, or CAPAs.
• Hands-on TrackWise experience highly valued.
• Ability to write and maintain clear procedures, operating standards, and work instructions.
• Strong cross-functional stakeholder management and communication skills.

Aufgaben

• Support end-to-end management of GMP-related Change Requests and Concept Changes in TrackWise to drive compliant supply chain execution.
• Partner with cross-functional stakeholders across Supply Chain, QA, Manufacturing, Engineering, and IT to perform risk assessments.
• Standardize recurring ways of working by developing, documenting, and maintaining clear SOPs, operating standards, and work instructions.
• Proactively monitor open change activities, follow up on action items, and ensure timely closure of records in line with QMS standards.
• Translate lessons learned and best practices into sustainable procedures, fostering continuous improvement and process simplification.
• Support audit and inspection readiness initiatives, ensuring documentation and quality systems meet strict regulatory expectations.
• Serve as a key subject matter expert, guiding cross-functional teams on TrackWise workflows and compliance standards.

Kenntnisse

TrackWise

Change Requests

Quality Assurance

Cross-functional collaboration

SOP writing

Documentation

English fluency

German knowledge

Jobbeschreibung

Lonza in Visp, Switzerland, seeks a GMP-focused QA/Supply Chain professional for a hybrid, fixed-term role. You will manage TrackWise change requests and concept changes, coordinate with QA, manufacturing, IT and engineering, and drive compliant, efficient drug manufacturing operations.

You will develop SOPs and work instructions, monitor change activities, and support audit readiness while enabling continuous improvement in a regulated environment. Fluency in English; German is a plus.