Quality Project Lead - Medical Devices & Combination Products

For a leading pharmaceutical company, we are looking for a qualified professional for a temporary assignment as

• Workplace:
  
  Basel, Switzerland
• Start Date:
  
  01.01.2027
• Duration: 12 months (extension possible based on project need)
• Workload:100% on Site

• Lead and support global Technical Research & Development (TRD) project teams on all quality-related topics across complex pharmaceutical development programs.
• Represent TRD QA in cross-functional project teams, quality governance boards, and development milestone reviews.
• Provide quality oversight and strategic guidance for development projects involving pharmaceutical products, medical devices, and combination products.
• Develop and implement project-specific quality strategies, risk assessments, and contingency plans to ensure successful project execution and delivery.
• Act as the key QA interface between TRD, Regulatory Affairs, Technical Operations, and external partners, ensuring alignment and compliance across all project activities.
• Support regulatory submission activities and prepare project teams for Health Authority inspections, Notified Body audits, Mock-PAIs, and Pre-Approval Inspections (PAIs).
• Review and support quality agreements, contracts, and collaborations with external partners and third-party organizations.
• Drive continuous improvement initiatives and contribute to global quality, compliance, and technology projects.

• Bachelor's degree with more than 10 years of experience in Pharmaceutical Quality, Quality Assurance, Quality Control, or Operations; alternatively a Master's degree with more than 5 years of relevant experience.
• Several years of hands-on experience in Medical Devices and Combination Products.
• Strong knowledge of pharmaceutical development, manufacturing processes, quality systems, cGMP requirements, and global regulatory standards.
• Proven experience supporting Health Authority inspections (FDA, EMA), Notified Body audits, and regulatory submissions (IND, IMPD, NDA, ANDA, MAA).
• Demonstrated ability to lead complex cross-functional projects and influence stakeholders in a global matrix organization.
• Excellent communication skills with fluent English;
  German language skills are desired.