Global QA Project Lead – Med Devices & Combo Products

Gi Life Sciences Basel; Basel; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Gi Life Sciences Basel is seeking a Quality Project Lead for a 12-month on-site assignment in Basel, Switzerland. You will head global TRD quality initiatives for medical devices and combination products, coordinating cross-functional teams and regulatory activities.

Qualified candidates hold a senior degree with extensive experience in pharmaceutical quality, quality systems, and regulatory submissions, and are fluent in English with German desirable.

Qualifikationen

• Bachelor's degree with >10 years in Pharmaceutical Quality, QA, QC, or Operations; or Master's with >5 years.
• Hands-on experience in Medical Devices and Combination Products.
• Strong knowledge of 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 in a global matrix organization.
• Excellent communication skills with fluent English; German desirable.

Aufgaben

• Lead and support global TRD project teams on quality topics across development programs.
• Represent TRD QA in project teams, governance boards, and milestone reviews.
• Provide quality oversight and guidance for projects involving products and combination devices.
• Develop and implement project-specific quality strategies and risk assessments.
• Act as QA interface between TRD, Regulatory Affairs, and external partners.
• Support regulatory submissions and inspections preparation (Health Authority, Notified Bodies).
• Review quality agreements with external partners and contracts.
• Drive continuous improvement across global quality and technology programs.

Kenntnisse

Pharmaceutical Quality

Quality Assurance

Cross-functional leadership

Regulatory submissions

Communication skills

English fluent

German language

Ausbildung

Bachelor's degree in related field

Master's degree (preferred)

Jobbeschreibung

Gi Life Sciences Basel is seeking a Quality Project Lead for a 12-month on-site assignment in Basel, Switzerland. You will head global TRD quality initiatives for medical devices and combination products, coordinating cross-functional teams and regulatory activities.

Qualified candidates hold a senior degree with extensive experience in pharmaceutical quality, quality systems, and regulatory submissions, and are fluent in English with German desirable.