Senior QA Project Lead – Combination Products (Global)

nemensis ag; Basel; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Benefits dieser Stelle

Consultant support

Large client network

Coaching during process

Zusammenfassung

Nemensis AG invites a Senior QA Project Lead for Combination Products to join our client’s global development teams in Basel. You will drive quality strategy and oversee programs at the intersection of drug products and medical devices, ensuring regulatory readiness and cGMP compliance.

You bring several years of hands-on QA experience in medical devices/combination products, with a strong track record in regulated environments and clear English communication. The role is on-site in Switzerland.

Qualifikationen

• Hands-on medical device/combination product QA experience required.
• Experience with FDA, EMA and Notified Body inspections.
• Knowledge of regulatory submission formats (INDs, IMPDs, NDAs, ANDAs, MAAs).
• Strong ability to guide interdisciplinary, matrix teams with quality focus.
• Fluent English; local language knowledge is a plus.

Aufgaben

• Act as the quality voice within global development project teams.
• Shape project strategy with development leads, including risk assessments.
• Provide quality oversight across development programs for combination products.
• Coordinate between quality and other departments; flag critical topics.
• Review third-party contracts and quality agreements; amend as needed.
• Prepare teams for Mock-PAI and PAI activities; ensure submission readiness.
• Contribute to cross-functional and global quality initiatives.

Kenntnisse

Quality assurance

Regulatory inspections

Cross-functional collaboration

Ausbildung

Bachelor's degree

Master's degree

Jobbeschreibung

Nemensis AG invites a Senior QA Project Lead for Combination Products to join our client’s global development teams in Basel. You will drive quality strategy and oversee programs at the intersection of drug products and medical devices, ensuring regulatory readiness and cGMP compliance.

You bring several years of hands-on QA experience in medical devices/combination products, with a strong track record in regulated environments and clear English communication. The role is on-site in Switzerland.