Description

Global Project Manager
Global Project Manager: Project Manager / Medical Device / Pharmaceutical / Biopharmaceutical / 21CFR820.30 / design control requirements / PMP / English / German
Background:
We 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.
The 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
Tasks & Responsibilities:
What You'll Do:
In 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:
Planning: Define "inspection ready" Design & Development Plans
Execution: Drive team activities to meet project and design control deliverables
Team Dynamics: 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
Project Management responsibilities:
Maintains full understanding of program milestones for the Core, Lifecycle, Technical Development and associated teams and links them to the Device Team plan
Effectively 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
Develops & updates Design & Development Plan and establishes contingency plans as needed
Ensures transparent communication of key team information and escalates issues as appropriate
Establishes positive team dynamics through team building
Promotes collaborative environment across team members
Facilitates efficient decision-making and issue resolution
Identifies team risks and mitigation plans
Project Planning and Execution:
Manages project scope and facilitate necessary changes
Facilitates project plan development and execution, and monitor the project schedule
Integrates deliverables with other teams linked to the product
Ensures effective team dynamics and positive team environments
Risk and Issue Management:
Anticipates and manage risks with proactive contingency plans
Facilitates risk management process and issue resolution
Collaboration and Team Building:
Assesses Team dynamics and leads team building activities to enable and sustain a high performing team environment
Establish relationships and network with other stakeholder Teams and PMs
Communication:
Develops and adapts project communication tools to drive awareness of project progress and risks across stakeholders including external collaborators (e.g. dashboard)
Acts as Device Team Leader back-up for Team communication as required
Liaises with other Teams to manage cross-functional activities and issues and risks
Meeting and Budget Management:
Facilitate effective team meetings with clear outcomes and follow-up actions
Forecast and monitor team resources and project costs
Knowledge Management:
Establishes centralized Team access to all relevant project information
Manages Team uncontrolled document repository (e.g. Project History File)
Conducts lessons learned exercises during project execution and share outcomes to a broader audience
Must Haves:
Bachelor's degree in Engineering or a related field.
8 to 11 years of experience, with at least 5 years in a relevant industry, preferably within a global medical device, pharmaceutical, or biopharmaceutical company
Experience in project management in drug and/or medical device development and commercialization, particularly with combination products
Proficiency in Project Management best practices and software (Microsoft Project, Smartsheet, Google suite)
PMP certification is an asset.
Knowledge of 21CFR820.30 design control requirements
Experience with vendor / partner collaboration.
Excellent communication and relationship-building skills.
Ability to manage complex projects independently in a fast-paced, team-based environment.
Fluent English is required. German, Japanese or Danish is of advantage
Reference Nr.: 925039
Rolle: Global Project Manager
Industrie: Pharma
Location: Basel
Pensum: 100%
Start: (Latest Start date )
Duration: 12 + Months
Deadline:
If 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.
Contact us for more information about our company, our positions, or our attractive payroll-only program: .
About us:
ITech 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. jid3548304a jit0626a jiy26a