QA Consultant - QMS Design & Inspection Readiness

Walker Cole International is currently partnered with a Biotech firm who is on the trajectory for continued growth. To support the future commercialisation of their current asset in the Clinic, we are searching for an oncoming hire of Consultant QA in Europe for a contract of 6 months initially for 2026.

The ideal candidate will have the following responsibilities:

1. QMS Design & Implementation
   Lead the end-to-end design, build, and deployment of a compliant Quality Management System (QMS) aligned to applicable regulations and standards (e.g., FDA, ISO, ICH), including policies, procedures, records, and governance frameworks.

2. Inspection Readiness Program
   Develop and execute a scalable inspection readiness strategy, including gap assessments, remediation planning, mock inspections, and readiness metrics to ensure sustained compliance and audit confidence.

3. Client Enablement & Stakeholder Leadership
   Partner with cross-functional client stakeholders to embed quality practices, deliver training and coaching, and establish ownership models that support long-term operational excellence beyond the engagement.

Contract details:

• Start date: 2026 February
• 2-4 days per week 
• 80-100 euros per hour (dependent on experience level)
• Duration of project: 6 months (with likely extension)
• Location: Europe - remote 

Quality Assurance l Operations l Quality l Inspection Readinessl QMS l Gap Assessment l Contract l Contractor l Biopharma l Biotech