Project Manager (m/f/d)

Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a

Project Manager (m/f/d)

Background:

As the Project Manager, closely collaborate with the Device Development Team Leader to drive the advancement of drug delivery technology platforms and portfolio development, playing a pivotal role in the successful delivery of life-changing medical devices to the clinic and market. Leverage a robust foundation in both technical engineering and project management to strategically plan, execute, and oversee development projects, ensuring timely completion, cost efficiency, and full compliance with regulatory requirements.

Tasks & Responsibilities:

• 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

Must Haves:

• 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
• 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
• Excellent communication and interpersonal 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
• Proven track record leading development projects and an in depth knowledge to apply project management methodologies and Design Control requirements
• Project Management: Successfully contributed to multiple medical device projects, ensuring timely delivery and adherence to budget constraints
• 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
• Risk Management: Adept at identifying project risks and implementing mitigation strategies to ensure project continuity and success
• High Performing Teams: Proven ability to cultivate, develop, and sustain high-performing teams that excel in collaboration, innovation, and efficiency
• Stakeholder Management: Proven ability to communicate effectively with team members and stakeholders, fostering a collaborative environment

Nice to Have:

• Experience in drug-device combination products is considered an asset
• 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

What you will be offered:

• An opportunity to work in one of the world's most important pharmaceutical companies
• Modern campus with plenty of green spaces and meeting areas
• Central location in Basel
• Varied job profile
• Further training opportunities through temptraining
• Working in a dynamic and motivated team
• Direct involvement in impactful healthcare projects, contributing to the development of life-changing medical devices
• Opportunity to expand your professional network within a global, multi-disciplinary environment

If you are interested please send your application documents addressed to Ms Kimberly Schneider.

Basel-Stadt Cross-functional Collaboration Product Lifecycle Management Global Project Coordination Globale Projektkoordination