Project Manager

Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competences within the Interiman Group, we offer tailor-made solutions in personnel consulting.

For our client F. Hoffmann - La Roche  in Basel, we are looking for a motivated and reliable (w/m/d)

Project Manager 100%

• Define project charter and scope. In collaboration with Device Development Leader, clearly define deliverables of the project following, making sure project assumptions, constraints and scope are shared and understood within the organization and within the overall Technical Development Team.
• Device Project deliverables: clearly plan project deliverables and forecast requirements, estimating team resources and budget.
• Project integration: generate comprehensive list of required documentation to make sure project information is readily accessible and allows seamless integration in collaboration with PMO for the overall projects portfolio.
• Manage change management for project scope changes, integrating a change-management mentality within a fast-paced and complex organization to assure constant stakeholders alignment.
• Schedule Management: Develop and maintain the project schedule, track progress.
• Budget Management: Plan and manage the project budget, monitor expenditures in collaboration with other governing committees and the overall Technical Development Team.
• Stakeholder Communication: Establish and maintain a solid communication with internal and external stakeholders, provide updates and regular status reports, manage expectations in a faceted stakeholder environment.
• Risk Management: Identify, monitor, and mitigate project risks and issues, informing
• Resource Management: Allocate and manage resources in collaboration with the Device Development Leader, including personnel and materials.
• Quality Management: Ensure project deliverables meet quality system requirements.

• BA/BS + a minimum of 15 years total work experience with at least 10 or more year's relevant business and/or technical experience in the medical device, pharmaceutical or biopharmaceutical industry preferably from a multi-site global company.
• Experience in drug-device combination products is considered an asset.
• At least 10 years Project Management experience - Project Management Professional (PMP) certification or equivalent is preferred.
• Proven experience in project management, including project planning, execution, and closure.
• Strong leadership and team management skills.
• Proficiency in project management software (e.g., MS Project, Smartsheet, Trello).
• Solid understanding of project management methodologies (e.g., Agile, Waterfall).
• Ability to manage multiple projects simultaneously and prioritize tasks effectively.
• Strong foundation in engineering, biotechnology, or life sciences relevant to medical device development
• Understanding of clinical, regulatory, and manufacturing requirements to ensure smooth device development and industrialization.
• Regulatory: Deep understanding of design controls, risk management, and quality systems (ISO 13485, FDA 21 CFR Part 820), with extensive knowledge of FDA regulations, ISO standards, and CE marking requirements to ensure strict compliance across all projects.

• Pharmaceutical E2E Drug Development - familiarity and understanding
• PMP certification
• Familiarity with digital integrated software solution that delivers an item-based data approach e.g. Polarion ALM, Veeva Vault