Senior Technical Project Manager (EMEA)

Company Description

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world. 

Job's Mission

To lead project management activities for technical projects as such or during the technical phase of a project. Such projects include but are not limited to new product launches, tech transfers, industrialisation projects, implementation of capex and change control projects such as new line qualifications and API and process changes, where the scope and magnitude of the project requires significant cross functional coordination.

To contribute to the development and rollout of project management best practices within the Product Supply Department.
 

Job Description

1. Execute project management according to the Santen Global Tech Transfer process for NPIs and Tech Transfers.
2. For assigned projects, be the single-point-of contact for production location (CMO), working directly with the corresponding CMO Project Manager, building the relationship to ensure alignment between the companies and seamless project execution.
3. For assigned CMOs, be a core member of the Supplier Relationship Team , representing Supply Chain Project Management team. As such, collaboratively responsible for CMO Performance.
4. Build the project teams as required according to the project deliverable, ensuring that relevant subject matter experts are allocated from the functions. Team members may include representatives from R&D, commercial, regulatory, quality, supply chain planning, External Manufacturing & Sourcing, finance and legal, as well as other ad-hoc members according to the specificity of the project.
5. Lead the cross-functional team, ensuring individual member responsibility for his/her deliverables and collective responsibility across the team for the overall successful deliverance of the project.    
6. Develop best practice project management processes and tools, providing detailed Gantt charts and project plans to ensure clarity and control of key activities, reporting regularly to management and ensuring visibility of the critical path and key decision milestones.
7. Identify risks to realizing the project on-time on-budget and, when necessary, establish a risk management plan to mitigate the identified risks. Assess the risks associated with the project, identify time-critical activities, and propose contingency plans to minimize potential consequences.
8. Develop and maintain appropriate documentation of processes and methods, ensure Santen’s knowledge on project management is kept up-to-date, learnings are shared and the training material for project members maintained up to date.
9. Run project activities in line with cGMP, ensuring that relevant systems are up to date and compliant with quality, regulatory and financial integrity.
10. Contribute to reporting within Global Product Supply team on predefined KPIs and collaborate on global initiatives to improve overall Project Management principles. 
     

Qualifications

1. Proven experience in Project Management leadership and execution, (New Product Launches, Transfers, Pruning, etc.), managing cross-functional teams to deliver projects on-time and on-budget.
2. 5+ years of cross-cultural project management experience within the pharma/healthcare environment, preferably including experience of working with external suppliers and with team members located across several countries.
3. Experience in a Tech Ops/product supply environment - supply chain management, production, new product introduction management (operational readiness), CMO management and/or site manufacturing is a big plus.
4. Advanced knowledge and on-hands experience of project management tools, like MS Project.
5. Understanding of product and financial flows within the Pharmaceutical/Medical Device/Healthcare Industry.
6. Full understanding of project management and project planning processes and tools with a view to executing such process to maintain supply and compliance with quality, regulatory and financial standards.
7. Understanding the end-to-end process of product supply from development with external partners through to delivery to the patient.  Aware of the source of risk and subsequent appropriate management of these risks.
8. Set expectation to the functions and clarify role and responsibilities to manage the deliverables in a timely manner, respecting cultural and functional challenges whilst maintaining a clear focus on the project goal.
9. Good understanding of global tech ops processes, able to contr