R&D / Tech Dev Quality Lead

RMIT Professional Resources AG seeks a Senior R&D / Tech Dev Quality Lead in Basel for an on-site contract role, focusing on quality oversight for global GDPD projects.

The company is looking for a senior professional to guide global GDPD project teams on all quality-related matters. This position provides essential quality oversight for assigned development initiatives, ensuring that strong technical guidance and input are maintained throughout the project lifecycle.

Responsibilities

• Create project quality strategies that align with GDPD standards, including risk assessments and contingency planning.
• Act as the QA DDS representative in expert panels, quality boards, project sub-teams, and development gate meetings.
• Assist with quality components of new technology projects and serve as the QA approver for technical documentation.
• Participate in drafting quality agreements, impact assessments, QMS documentation, and regulatory change evaluations.
• Support inspection processes, review deviations, manage OOX records, and assess change impacts.

Requirements

• A Bachelor’s degree with over 10 years of experience in pharma quality or operations, or a Master’s degree with more than 5 years in these areas.
• Demonstrated background in quality management within medical devices, drug delivery systems, or similar development settings.
• Deep knowledge of quality systems, regulatory demands, and compliance procedures specific to medical devices.
• Experience facilitating cross-functional projects, covering technical documentation, risk management, and governance.
• Fluent proficiency in English, both spoken and written.

Nice to have

• Competence in the local site language, particularly for oral communication.