Quality Project Lead - Medical Devices & Combination Products
Job in
4040, Basel, Kanton Basel-Landschaft, Switzerland
Listed on 2026-09-12
Listing for:
Gi Life Sciences Basel
Seasonal/Temporary
position Listed on 2026-09-12
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering -
Pharmaceutical
Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
For a leading pharmaceutical company, we are looking for a qualified professional for a temporary assignment as
Quality Project Lead - Medical Devices & Combination Products (m/f/d)General Information:
- 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.
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