Quality Project Lead, Medical Devices & Combo Products

Gi Life Sciences Basel; Basel; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Gi Life Sciences Basel is seeking a qualified professional for a temporary assignment as Quality Project Lead - Medical Devices & Combination Products (m/f/d) in Basel, Switzerland. Lead TRD QA on global development programs, represent QA in cross-functional teams, and guide quality strategies; support regulatory submissions and inspections.

A Bachelor's degree with 10+ years in Pharmaceutical Quality or related fields is required; experience with Medical Devices and combination products is

Qualifikationen

• Bachelor's degree with 10+ years in Pharmaceutical Quality or related areas.
• Experience in Medical Devices and Combination Products.
• Knowledge of 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.

Aufgaben

• Lead and support global TRD project teams on quality topics across development programs.
• Represent TRD QA in cross-functional project teams, governance boards and reviews.
• Provide QA oversight and guidance for development projects involving pharma, devices, and combos.
• Develop and implement project-specific quality strategies, risk assessments, and contingency plans.
• Act as QA interface between TRD, Regulatory Affairs, Technical Ops and external partners.
• Support regulatory submissions and prepare teams for inspections and audits.
• Review quality agreements and collaborations with external partners.
• Drive continuous improvement across global quality and tech programs.

Kenntnisse

Cross-functional leadership

Quality management

Regulatory liaison

Project governance

Stakeholder influence

Communication (English)

Ausbildung

Bachelor's degree in related field

Master's degree (advantage)

Jobbeschreibung

Gi Life Sciences Basel is seeking a qualified professional for a temporary assignment as Quality Project Lead - Medical Devices & Combination Products (m/f/d) in Basel, Switzerland. Lead TRD QA on global development programs, represent QA in cross-functional teams, and guide quality strategies; support regulatory submissions and inspections.

A Bachelor's degree with 10+ years in Pharmaceutical Quality or related fields is required; experience with Medical Devices and combination products is