Global Medical Device QA Project Lead - Flexible Hours

edp personalberatung gmbh; Basel; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

pharmaceutical company in Basel, Switzerland, seeks a Project Manager in Medical Device/QA (m/f/d) for 100% capacity on a temporary basis (01.01.2027 - 31.12.2027, with extension). The role involves leading TRD QA activities, ensuring quality oversight across development projects, and aligning with cGMP guidelines.

Flexible hours and a multicultural team are highlighted. Qualifications include a Bachelor Degree with >10 years in pharma quality or operations, fluent English, and German or French

Qualifikationen

• Bachelor Degree with >10 years in pharma quality or operations.
• Masters Degree with >5 years in pharma quality or operations (desirable).
• Fluent English (oral + written) and good German or French.
• Strong understanding of quality standards in Drug Product/Medical Devices manufacturing.
• Experience with Health Authority inspections (FDA/EMA) and Notified Body inspections.
• Knowledge of RegCMC requirements for NB and Health Authority submissions.
• Broad experience in combination product development and QA/QC.

Aufgaben

• Lead and support global TRD project team and represent TRD QA in global meetings.
• Ensure quality oversight on development projects with guidance and expertise.
• Contribute to project strategy, contingency planning, and risk assessments to meet quality deliverables.
• Manage interactions between TRD QA and other departments.
• Communicate project strategy and critical topics to management and project teams.
• Input to contracts and QA agreements with third parties; approve amendments.
• Lead or participate in global/cross-functional initiatives.
• Prepare and guide TRD project teams for Mock-PAI and PAI during preparation.

Kenntnisse

Bachelor degree

10+ years pharma QA

Masters degree

5+ years pharma QA

English (fluent)

German or French

Quality standards

Health Authority inspections

Notified Body inspections

RegCMC knowledge

Combination product development

Technical Operations

Interdisciplinary teams

Ausbildung

Bachelor Degree

Master Degree

Jobbeschreibung

pharmaceutical company in Basel, Switzerland, seeks a Project Manager in Medical Device/QA (m/f/d) for 100% capacity on a temporary basis (01.01.2027 - 31.12.2027, with extension). The role involves leading TRD QA activities, ensuring quality oversight across development projects, and aligning with cGMP guidelines.

Flexible hours and a multicultural team are highlighted. Qualifications include a Bachelor Degree with >10 years in pharma quality or operations, fluent English, and German or French