Quality Project Lead - Medical Devices & Combination Products (m/f/d)

仕事内容

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:  Duration: 12 months (extension possible based on project need) Workload: 100% on Site Your Responsibilities 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. Your Profile 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. Interested? Then apply today! We look forward to hearing from you. j4id10383784cs j4it0937cs j4iy26cs

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