Project Manager

Proclinical Staffing; Basel; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

Proclinical Staffing is seeking a Project Manager with quality assurance expertise for medical devices and combination products. Lead global project teams, drive QA strategies, and ensure regulatory compliance across development programs.

You will oversee QA activities, interact with Health Authorities, and guide project strategies to meet submission timelines. English fluency is required, with additional languages a plus, and EU work rights or location-specific eligibility is necessary.

Qualifikationen

• Experience leading QA-focused projects for medical devices or combination products.
• Knowledge of regulatory pathways and submissions (FDA/EMA) for devices and drug-device combos.
• Proven ability to guide global project teams and align QA with development timelines.

Aufgaben

• Lead and support global project teams, representing QA in sub-teams and governance meetings.
• Provide QA oversight on development projects with strategic and technical guidance.
• Develop project strategies, risk assessments, and contingency plans to ensure timely delivery of quality outcomes.
• Ensure alignment with cGMP and internal QA procedures across programs.
• Coordinate interactions between QA and other functions and external partners.
• Communicate project status and critical updates to stakeholders and management.
• Contribute to contracts and QA agreements with third parties and approve amendments.
• Lead or participate in global, cross-functional initiatives.
• Prepare teams for inspections, including Mock-PAI and PAI activities.

Kenntnisse

Quality assurance

Regulatory compliance

Project management

Cross-functional teamwork

cGMP knowledge

FDA inspections

Notified Body inspections

IND/IMPD submissions

Tools

MS Office

Document management

Jobbeschreibung

Looking to to lead projects that bring life-changing treatments to the world? Join our client at the forefront of pharmaceutical innovation and make a difference!

Proclinical is seeking a Project Manager with expertise in quality assurance for medical devices and combination products. In this role, you will lead complex projects and quality initiatives, providing strategic guidance and support to global teams. You will play a key role in ensuring compliance with regulatory standards and driving the quality of deliverables across projects.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Lead and support global project teams, representing QA in sub-teams, quality board meetings, and development gate meetings.
• Provide quality oversight on assigned development projects, offering strong guidance and technical expertise.
• Develop and implement project strategies, including contingency planning and risk assessments, to ensure timely delivery of quality outcomes.
• Ensure alignment of project strategies with QA goals and compliance with cGMP guidelines and internal procedures.
• Manage interactions between QA and other departments, both internally and externally.
• Communicate project strategies, key issues, and critical updates to stakeholders and management in a timely manner.
• Contribute to contracts and QA agreements with third parties, approving project-specific amendments as needed.
• Lead or participate in global and cross-functional initiatives.
• Prepare and guide project teams for inspections, including Mock-PAI and PAI, as part of submission preparation processes.

Key Skills and Requirements:

• Strong understanding of quality standards and policies in drug product and medical device/combination product manufacturing and control.
• Experience with Health Authority inspections (e.g., FDA, EMA) and Notified Body inspections.
• Knowledge of regulatory requirements for submissions (e.g., INDs, IMPDs, NDAs, ANDAs, MAAs).
• Proven experience in combination product development and quality assurance or quality control.
• Familiarity with technical operations or equivalent experience in external companies.
• Demonstrated ability to support interdisciplinary teams and contribute to matrix teams with strategic thinking and quality awareness.
• Proficiency in computer systems, including MS Office and document management systems, with a willingness to learn new tools.
• Fluent in English (oral and written); proficiency in additional languages is a plus.