Quality Project Lead - Medical Devices & Combination 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

For a leading pharmaceutical company, we are looking for a qualified professional for a temporary assignment as

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

General Information:

• Workplace:Basel, Switzerland
• 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.