About Our Client
Prestigious biotech company
Temporary 12 month contract with option to extend or go permanent.
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.
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