Overview
You lead QA-driven, global projects that bring life-changing therapies to market. You provide strategic QA guidance across development teams, ensuring cGMP compliance and high-quality deliverables. You drive inspection readiness and regulator-facing activities, shaping submissions and third-party contracts. This role combines cross-functional leadership with rigorous quality oversight in a fast-paced, global setting.
Verantwortungsbereiche
- Lead global project teams with QA representation in sub-teams, quality boards, and development gate reviews
- Provide QA oversight on development projects with technical guidance
- Develop and implement project strategies, including risk assessments and contingency planning
- Ensure strategies align with QA goals and cGMP/internal procedures
- Manage QA interactions with internal and external stakeholders
- Communicate strategies, issues, and updates to management in a timely manner
- Contribute to contracts and QA agreements with third parties and approve amendments
- Lead or participate in global, cross-functional initiatives
- Prepare project teams for inspections (Mock-PAI and PAI) as part of submission readiness
Zentrale Anforderungen
- Strong understanding of QA standards in drug product and medical device/combination product manufacturing and control
- Experience with Health Authority inspections (FDA, EMA) and Notified Body inspections
- Knowledge of regulatory submissions (INDs, IMPDs, NDAs, ANDAs, MAAs)
- Proven experience in combination product development and QA/QC
- Familiarity with technical operations or equivalent external-company experience
- Ability to support interdisciplinary/matrix teams with strategic thinking and quality awareness
- Proficiency with MS Office and document management systems; willingness to learn new tools
- English fluency; additional languages a plus
- Cross-functional collaboration
- Strategic thinking
- Strong communication
- QA for medical devices and combination products
- Regulatory inspections (FDA, EMA, Notified Bodies)
- Regulatory submissions (INDs, IMPDs, NDAs, ANDAs, MAAs)
Project Manager in Basel Arbeitgeber: ProClinical
Proclinical ist ein hervorragender Arbeitgeber, der eine dynamische und unterstützende Arbeitsumgebung bietet, in der Mitarbeiter ihre Fähigkeiten im Vertrieb im Gesundheitswesen voll entfalten können. Mit einem starken Fokus auf Teamarbeit und persönlicher Entwicklung fördert das Unternehmen eine Kultur des Wachstums und der Exzellenz, während es gleichzeitig die Einhaltung ethischer Standards und gesetzlicher Vorschriften sicherstellt. Die Position des National Sales Manager in Deutschland bietet nicht nur die Möglichkeit, einen bedeutenden Einfluss auf den Markt auszuüben, sondern auch Zugang zu umfangreichen Ressourcen und einem Netzwerk von Fachleuten, die sich leidenschaftlich für die Verbesserung der Gesundheitsversorgung einsetzen.
