R&D / Technical Development Quality Lead

CTC Resourcing Solutions AG seeks a Lead for R&D and Technical Development Quality in Basel. This 10-month on-site role supports global medical device projects within the GDPD team.

Operating within the Global Device and Packaging Development (GDPD) team, this position drives quality initiatives across international medical device projects. The role serves as a key quality authority, ensuring regulatory alignment and guiding project teams through development phases.

Responsibilities

• Provide quality oversight and strategic guidance to global GDPD project teams.
• Represent the Drug Delivery Systems quality function in sub-teams, quality boards, and gate meetings.
• Create project strategies that align with quality goals and regulatory standards.
• Serve as the official Quality Approver for technical documentation, deviations, and quality agreements.
• Assist with Notified Body inspections and maintain compliance with EU MDR and FDA regulations.
• Partner with cross-functional groups to ensure smooth project execution.
• Update Quality Management System documentation and support continuous improvement efforts.

Requirements

• Hold a valid Swiss or EU work permit, or possess Swiss/EU citizenship.
• Possess a Bachelor’s degree in a relevant field (such as Pharmacy or Biomedical Engineering) along with over 10 years of experience in pharma or medical device quality/operations.
• Alternatively, hold a Master’s degree with more than 5 years of relevant experience.
• Demonstrate a strong background in medical device development, quality assurance, or quality control.
• Have prior experience managing Notified Body inspections and ensuring regulatory compliance.
• Show proven leadership capabilities within interdisciplinary teams.
• Communicate fluently in English, both verbally and in writing.

About the company

The client is a major global pharmaceutical company headquartered in Basel, Switzerland. They specialize in novel therapies for Oncology and Ophthalmology while building a leading pipeline in Neuroscience and Dermatology.

• Global presence with headquarters in Basel.
• Focus on innovative therapies in Oncology and Ophthalmology.
• Development of advanced pipelines in Neuroscience and Dermatology.