pbGlobal Project Manager: Project Manager / Medical Device / Pharmaceutical / Biopharmaceutical / 21CFR820.30 / design control requirements / PMP / English / German /b /ppbBackground: /b /p pWe are looking for a Principal Project Manager (PM) to manage a range of projects, based on their stage and complexity. This role encompasses a variety of assignments including development pipeline, line extensions, post-approval, technology, and continuous improvement initiatives. The PM will work independently, effectively prioritizing and managing workload to meet team goals with limited direction. The role includes flexibility for global time zone interactions and occasional travel to external partners for collaboration and planning activities. /p pThe Perfect Candidate holds a Bachelor’s degree in Engineering or a related field, supported by 8 to 11 years of professional experience, including a minimum of 5 years within the medical device, pharmaceutical, or biopharmaceutical sectors. They should possess significant expertise in managing drug or medical device development and commercialization projects, with a focus on combination products and vendor collaboration. Proficiency in industry-standard project management tools, such as Microsoft Project, Smartsheet, and Google Suite, is required, alongside a thorough understanding of 21CFR820.30 design control requirements. A PMP certification is considered a valuable asset for this role. Furthermore, the candidate should demonstrate the ability to manage complex projects independently within a fast-paced environment and possess excellent communication and relationship-building skills. Fluency in English is required, while proficiency in German, Japanese, or Danish is advantageous /p pbTasks Responsibilities: /b /p pbWhat You’ll Do: /b /p liIn collaboration with the Technical Development Team Lead (TDTL) Device Team Leader (DTL), the PM will translate device strategy into actionable plans, focusing on three key areas: /li pbPlanning: /b Define „inspection ready“ Design Development Plans /p pbExecution: /b Drive team activities to meet project and design control deliverables /p pbTeam Dynamics: /b Ensure effective communication and facilitate team performance in a regulated environment using various processes and tools for planning, communication, budget, schedule, compliance, and risk management /p pbProject Management /bbresponsibilities: /b /p liMaintains full understanding of program milestones for the Core, Lifecycle, Technical Development and associated teams and links them to the Device Team plan /li liEffectively applies PM best practices and utilizes tools for planning, communication, team building, collaboration, decision-making, issue risk management, lessons learned, knowledge management and budget tracking /li liDevelops updates Design Development Plan and establishes contingency plans as needed /li liEnsures transparent communication of key team information and escalates issues as appropriate /li liEstablishes positive team dynamics through team building /li liPromotes collaborative environment across team members /li liFacilitates efficient decision-making and issue resolution /li liIdentifies team risks and mitigation plans /li pbProject Planning and Execution: /b /p liManages project scope and facilitate necessary changes /li liFacilitates project plan development and execution, and monitor the project schedule /li liIntegrates deliverables with other teams linked to the product /li liEnsures effective team dynamics and positive team environments /li pbRisk and Issue Management: /b /p liAnticipates and manage risks with proactive contingency plans /li liFacilitates risk management process and issue resolution /li pbCollaboration and Team Building: /b /p liAssesses Team dynamics and leads team building activities to enable and sustain a high performing team environment /li liEstablish relationships and network with other stakeholder Teams and PMs /li pbCommunication: /b /p liDevelops and adapts project communication tools to drive awareness of project progress and risks across stakeholders including external collaborators (e.g. dashboard) /li liActs as Device Team Leader back-up for Team communication as required /li liLiaises with other Teams to manage cross-functional activities and issues and risks /li pbMeeting and Budget Management: /b /p liFacilitate effective team meetings with clear outcomes and follow-up actions /li liForecast and monitor team resources and project costs /li pbKnowledge Management: /b /p liEstablishes centralized Team access to all relevant project information /li liManages Team uncontrolled document repository (e.g. Project History File) /li liConducts lessons learned exercises during project execution and share outcomes to a broader audience /li pbGovernance: /b /p liEffectively navigates the Device Team through business process stage-gates /li liSupports Team Leader with technical advisory and governance committee reviews at pre-defined check-in points and/or identifies appropriate check-in points /li pbContinuous Improvement Initiatives: /b /p liLeads business process continuous improvement initiatives through applying project lessons: business process updates, PM tool optimization implementation, best practice sharing and driving awareness across teams /li pbMust Haves: /b /p liBachelor’s degree in Engineering or a related field. /li li8 to 11 years of experience, with at least 5 years in a relevant industry, preferably within a global medical device, pharmaceutical, or biopharmaceutical company /li liExperience in project management in drug and/or medical device development and commercialization, particularly with combination products /li liProficiency in Project Management best practices and software (Microsoft Project, Smartsheet, Google suite) /li liPMP certification is an asset. /li liKnowledge of 21CFR820.30 design control requirements /li liExperience with vendor / partner collaboration. /li liExcellent communication and relationship-building skills. /li liAbility to manage complex projects independently in a fast-paced, team-based environment. /li liFluent English is required. German, Japanese or Danish is of advantage /li pbReference Nr.: /bbr/bRolle: Global Project Manager /bbr/bIndustrie: Pharma /bbr/bLocation: Basel /bbr/bPensum: 100% /bbr/bStart: (Latest Start date ) /bbr/bDuration: 12 + Months /bbr/bDeadline: 30/06/2026 /b /p pbIf this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume via this ad or to jobs(at)itcag(dot)com. /b /p pContact us for more information about our company, our positions, or our attractive payroll-only program: . /p pAbout us: /p pITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services. /p