Flexible Global Medical Device QA Project Lead

IWB Hauptsitz; Basel; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Basel Therapeutics is seeking a Project Manager in Medical Device/QA (m/f/d) for a 100% role on a temporary basis (01.01.2027 – 31.12.2027, with extension). You will lead global TRD QA projects, ensure quality oversight, and shape project strategies in alignment with cGMP and regulatory requirements.

A multicultural team and extensive training are offered. Requirements include a Bachelor’s degree with 10+ years in pharma quality or operations, fluency in English, plus German or French skills,

Qualifikationen

• Minimum: Bachelor Degree with >10 years pharma quality or operations experience.
• Desirable: Masters Degree with >5 years pharma quality or operations experience.
• Fluent English (oral + written); good German or French skills.
• Broad understanding of quality standards in Drug Product/Medical Devices (combination products).
• Experience with Health Authority Inspections (FDA and EMA) and Notified Body inspections; RegCMC knowledge for NB and submissions.

Aufgaben

• Lead and support global TRD project team; represent TRD QA globally.
• Ensure quality oversight on development projects with strong QA guidance.
• Contribute to project strategy, contingency planning and risk assessments.
• Coordinate interactions between TRD QA and other departments.
• Communicate project strategy and critical topics to management and teams.
• Provide input to contracts and QA agreements with third parties; approve amendments.
• Lead or participate in global cross-functional initiatives.
• Prepare TRD project teams for Mock-PAI and PAI preparations.

Kenntnisse

English fluency

German or French

Quality Assurance

Regulatory inspections

Cross-functional teamwork

Ausbildung

Bachelor's degree

Master's degree

Jobbeschreibung

Basel Therapeutics is seeking a Project Manager in Medical Device/QA (m/f/d) for a 100% role on a temporary basis (01.01.2027 – 31.12.2027, with extension). You will lead global TRD QA projects, ensure quality oversight, and shape project strategies in alignment with cGMP and regulatory requirements.

A multicultural team and extensive training are offered. Requirements include a Bachelor’s degree with 10+ years in pharma quality or operations, fluency in English, plus German or French skills,