Medical Device QA Project Manager

Actalent; Basel; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

Actalent seeks an expert Quality Assurance Project Manager with experience in medical devices (combination product) to lead global project teams on quality topics. This role focuses on QA oversight of development projects, aligning strategies with cGMP requirements and internal procedures, and guiding teams through PAI preparation and submission processes.

The ideal candidate brings a strong background in pharma quality or operations, with a track record of coordinating cross-functional teams

Qualifikationen

• Bachelor or higher in a relevant field with substantial pharma quality/operations exposure.
• Masters degree is desirable with significant pharma quality or operations experience.

Aufgaben

• Ensure quality oversight on development projects with strong quality guidance, scientific and technical expertise.
• Contribute to project strategy including contingency planning and risk assessments to ensure timely quality deliverables in line with QA strategies and cGMP.
• Communicate project strategy, key issues and critical topics to management.
• Prepare and guide project teams for Mock-PAI and PAI in the frame of the PAI preparation process and submission preparation.

Ausbildung

Bachelor

Masters

Jobbeschreibung

Our client, key player in the life sciences industry, is looking for an expert Quality Assurance Project Manager with experience in medical devices (combination product), to lead global project teams in all quality-relevant topics.

Responsibilities

• Ensure quality oversight on the assigned development projects with strong quality guidance, scientific and technical expertise
• Contribute to the strategy of assigned projects incl. contingency planning and risk assessments as appropriate to ensure timely achievement of project quality deliverables. Ensure that the strategy followed within the assigned projects is in line with QA strategies and goals, in compliance to cGMP guidelines and internal procedures
• Communicate project strategy, key issues, and any other critical topics to the appropriate management level
• Prepare and guide project teams for Mock-PAI and PAI in the frame of the PAI preparation process and submission preparation

Requirements

• Minimum education: Bachelor, with 10 years’ pharma quality or operations
• Desirable: Masters, with 5 years’ pharma quality or operations
• Experience in the medical device / combination product area

*Please note that we can only consider EU/Schengen applications, or valid Swiss permit.