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.

Key facts:

• Assignment period: 01.01.2027 – 31.12.2027 (extension possible)
• Location: Basel / Nordwestschweiz
• Employment type: Temporary placement

About Our Client

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.

Your Responsibilities

• 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

Your Profile

• 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

What Nemensis Offers You

• 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

Ready for Your Next Move?

At nemensis ag, we've already connected thousands of candidates with their dream jobs – helping them grow professionally or find their way back into the job market. What can we do for you and your career today? Get in touch with us about this Senior QA Project Lead Combination Products (m/f/d) role in Basel/Nordwestschweiz!

Branche: Pharmaindustrie

Funktion: Qualitätskontrolle / Qualitätssicherung

Anstellungsart: Befristeter Vertrag

Karrierestufe: Angestellte/r