• Prestigious biotech company
• Temporary 12 month contract with option to extend or go permanent.

About Our Client

Prestigious biotech company

Job Description

• Provide quality oversight of internal and external GxP operations and lead, coordinate, and troubleshoot quality investigations, ensuring thorough root cause analysis and implementation of appropriate CAPAs
• Take ownership of quality issues and drive them to full resolution in close collaboration with Supply Chain, Manufacturing, Clinical Operations, Regulatory Affairs, and other stakeholders
• Monitor and manage temperature excursions, deviations, and complaints in a timely and compliant manner
• Act as Subject Matter Expert (SME) for deviation management and change control processes
• Analyze and resolve quality and operational process anomalies, providing compliant and pragmatic solutions aligned with global and EU requirements
• Support audits and inspections and contribute to regulatory submissions as required
• Collaborate cross-functionally to develop, implement, and maintain policies, procedures, and SOPs
• Work closely with EU Qualified Persons to ensure compliance with applicable European regulations and directives
• Coordinate and manage Management Review activities, including data collection, KPI analysis, stakeholder alignment, and follow-up on actions and improvements
• Lead and manage Quality Agreements with internal and external partners, ensuring alignment with GMP, GDP/GSP, and applicable legal requirements, including Swiss regulations
• Collaborate closely with the Swiss Responsible Person and Deputy to ensure compliance with Swiss regulatory requirements
• Monitor performance metrics and provide regular updates to management, including escalation of risks and challenges
• Develop and support training materials and programs related to quality processes and standards
• Contribute to continuous improvement initiatives across Quality and Supply Chain functions
• Perform additional duties as assigned

The Successful Applicant

• Bachelor's degree in a scientific discipline or an equivalent combination of education and relevant work experience
• 3-6 years of experience in the pharmaceutical or biotechnology industry
• Experience working with Investigational Medicinal Products (IMPs)
• Strong knowledge of GMP and GDP, ideally within a drug development environment
• Experience in quality functions and cross-functional collaboration with manufacturing and supply chain teams
• Understanding of global and local GCP regulations is an advantage
• Experience working with external partners such as CMOs is preferred
• Strong analytical and problem-solving skills with the ability to manage complex quality issues
• Excellent communication and stakeholder management skills
• Proactive, detail-oriented, and able to manage multiple priorities in a dynamic environment
• Strong sense of ownership, accountability, and collaboration

What's on Offer

Interested to take you next step within quality?
Happy to review your application.

Quote job ref

JN-062026-7031509

Job Function

Healthcare & Life Sciences

Specialisation

Biotechnology

Industry

Healthcare / Pharmaceutical

Location

Basel

Contract Type

Interim

Job Reference

JN-062026-7031509

Job Nature

Home Office