Global Quality Project Lead - Medical Devices & Combos

Gi Group; Basel; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

Gi Group in Basel is seeking a Quality Project Lead for Medical Devices & Combination Products to drive quality strategies across pharmaceutical development programs. 100% on-site role for 12 months, with potential extension based on project needs.

The position requires extensive experience in pharmaceutical quality, medical devices, and combination products, with strong knowledge of cGMP and global regulatory standards. Fluent English is essential and German is a plus.

Qualifikationen

• Bachelor's degree with more than 10 years of experience in Pharmaceutical Quality, Quality Assurance, Quality Control, or Operations; or a Master's with more than 5 years of relevant experience.
• Hands-on experience in Medical Devices and Combination Products.
• Strong knowledge of pharmaceutical development, manufacturing, quality systems, cGMP, and global regulatory standards.
• Experience supporting Health Authority inspections (FDA, EMA) and regulatory submissions (IND, IMPD, NDA, ANDA, MAA).
• Ability to lead complex cross-functional projects and influence stakeholders in a global matrix organization.

Aufgaben

• Lead and support global TRD project teams on all quality-related topics across complex development programs.
• Represent TRD QA in cross-functional project teams, quality governance boards, and 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 for successful delivery.
• Act as the key QA interface between TRD, Regulatory Affairs, Technical Operations, and external partners.

Kenntnisse

Quality Assurance

Quality Control

Regulatory knowledge

Cross-functional leadership

Communication skills

English fluency

Ausbildung

Bachelor's degree + >10 years experience

Master's degree + >5 years experience

Jobbeschreibung

Gi Group in Basel is seeking a Quality Project Lead for Medical Devices & Combination Products to drive quality strategies across pharmaceutical development programs. 100% on-site role for 12 months, with potential extension based on project needs.

The position requires extensive experience in pharmaceutical quality, medical devices, and combination products, with strong knowledge of cGMP and global regulatory standards. Fluent English is essential and German is a plus.