Project Manager Pharmaceutical Development Combination Products(m/w/x)

Anforderungen

• Degree in sciences, pharmacy, engineering, or related field with relevant experience
• Project Management Professional (PMP) Certification preferred
• Experience in combination product, medical device, or pharmaceutical industry
• Leadership of technical professionals and cross-functional teams
• Skill in project management and unique problem solving
• Understanding of pharmaceutical product development cycle
• Experience in design history file and product development
• Conflict resolution, communication, and people management skills
• Execution of reportable device combination product events
• Understanding of GMP principles and global regulatory requirements
• Fluency in English and German preferred

Aufgaben

• Lead cross-functional teams across Engineering, Quality, and Operations
• Execute projects for combination product delivery systems
• Manage device, packaging, and labeling development
• Align project strategies with patient and business needs
• Support CMC gate reviews and clinical phase plans
• Deliver on project portfolio strategy and budget
• Manage external device partners tactically and strategically
• Oversee project governance and evaluate potential partners
• Manage device budgets, forecasting, and long-range planning
• Represent R&D to cross-functional leadership
• Define meeting objectives, agendas, and action items
• Drive continuous improvement for project management tools
• Manage project managers responsible for device development
• Monitor partner performance and schedule adherence
• Implement project scope and change control processes
• Identify and mitigate risks throughout the project lifecycle
• Communicate partner performance to the broader organization
• Define and track performance against Statements of Work
• Provide accurate cost estimates for financial forecasting
• Influence the development and launch of complex assets

Berufserfahrung

Ausbildung

Sprachen

Tools & Technologien