Projektmanager:in

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

Quality Project Lead - Medical Devices & Combination Products (m/f/d)

General Information:

• Start Date: 01.01.2027
• Duration: 12 months (extension possible based on project need)
• Workload: 100% on Site

Your Responsibilities

• Lead and support global Technical Research & Development (TRD) project teams on all quality-related topics across complex pharmaceutical development programs.
• Represent TRD QA in cross-functional project teams, quality governance boards, and development 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 to ensure successful project execution and delivery.
• Act as the key QA interface between TRD, Regulatory Affairs, Technical Operations, and external partners, ensuring alignment and compliance across all project activities.
• Support regulatory submission activities and prepare project teams for Health Authority inspections, Notified Body audits, Mock-PAIs, and Pre-Approval Inspections (PAIs).
• Review and support quality agreements, contracts, and collaborations with external partners and third-party organizations.
• Drive continuous improvement initiatives and contribute to global quality, compliance, and technology projects.

Your Profile

• Bachelor's degree with more than 10 years of experience in Pharmaceutical Quality, Quality Assurance, Quality Control, or Operations; alternatively a Master's degree with more than 5 years of relevant experience.
• Several years of hands-on experience in Medical Devices and Combination Products.
• Strong knowledge of pharmaceutical development, manufacturing processes, quality systems, cGMP requirements, and global regulatory standards.
• Proven experience supporting Health Authority inspections (FDA, EMA), Notified Body audits, and regulatory submissions (IND, IMPD, NDA, ANDA, MAA).
• Demonstrated ability to lead complex cross-functional projects and influence stakeholders in a global matrix organization.
• Excellent communication skills with fluent English; German language skills are desired.