Senior QA Project Lead Combination Products; m​/f​/d

Senior QA Project Lead Combination Products (m/f/d)

Senior QA Project Lead Combination Products (m/f/d)

Your Next Chapter Starts Where Science Meets Precision

Are you ready to bring your combination product and medical device quality expertise into high-impact, global development projects? For our client, join a team where your judgment on quality strategy directly shapes the success of complex pharmaceutical programs.

• Employment type: Temporary placement

Our client is a globally active pharmaceutical company with a strong footprint in technical research and development, known for pioneering work at the intersection of drug products and medical devices/combination products
. As Senior QA Project Lead Combination Products (m/f/d), you'll join an organization that combines scientific depth with a rigorous, quality-first culture and a track record of successful health authority interactions worldwide.

• Act as the quality voice within global development project teams, representing quality interests in cross-functional sub-teams, quality boards, and development gate meetings
• Shape project strategy together with development leads, including contingency planning and risk assessments, to keep quality deliverables on track and compliant with cGMP standards
• Provide scientific and technical quality oversight across assigned development programs, particularly those involving combination products
• Anticipate and steer the interplay between quality functions and other departments, flagging critical topics to the right stakeholders at the right time
• Review and contribute to third-party contracts and quality agreements, approving project-specific amendments where required
• Prepare and coach project teams ahead of Mock-PAI and PAI activities as part of submission readiness
• Contribute to or lead cross-functional and global quality initiatives beyond individual projects

• Several years of hands-on experience in medical device/combination product quality assurance – this is a mandatory requirement
• University degree (Bachelor's or Master's) combined with a substantial track record in pharmaceutical quality or operations roles
• Solid understanding of quality standards for drug product and medical device manufacturing, plus experience with FDA, EMA, and Notified Body inspections
• Familiarity with regulatory submission formats (INDs, IMPDs, NDAs, ANDAs, MAAs) and their quality-related requirements
• Proven ability to guide interdisciplinary, matrix-style project teams with strategic thinking and strong quality awareness
• Fluent English (spoken and written); working knowledge of the local site language is a plus
• Confident use of standard office and document management systems, along with openness to new tools and processes

• Nemensis AG is your specialised recruitment partner in Life Sciences, based in Basel
• Comprehensive guidance and support throughout your application process by our consultants
• Access to a large client network and exciting positions across Northwestern Switzerland
• A fast, uncomplicated path to your next role through personalised support and coaching during the application process