[Netherlands] QA Associate Director in Project Management (EMEA)

Company Description

As a specialized company dedicated to eye health, Santen aspires to contribute to the realization of “Happiness with Vision” by providing valuable products and services to patients, consumers, and medical professionals around the organization. Since its establishment in Japan in 1890, and guided by its CORE PRINCIPLE, “Tenki ni sanyo suru,” Santen has been committed to helping people maintain and improve their eye health, and is engaged in the global research and development, manufacturing, and sales and marketing of pharmaceutical products in the field of eye care, supporting the eye health of approximately 50 million people worldwide. Our duty is to create a future in which as many patients and consumers as possible can lead happy and fulfilling lives, we will continue to contribute to the realization of better eye care by providing solutions that eliminate bottlenecks in the diagnosis and treatment of eye diseases, thereby revolutionizing the treatment flow.
Each of us is deeply committed to challenging ourselves, building an organization that brings together diverse internal talents and external expertise, and to doing our utmost to realize a society in which people everywhere can feel happy through vision-related experiences. Isn't it exactly the kind of environment you want to belong in?

Job Description

Job’s mission

In compliance with any internal and external (GxP, ISO…) applicable requirements, the position holder:

• Leads and coordinates all quality aspects of the delivery of any new products to the business, including market expansions and lifecycle management.
• Leads and coordinates the department performance management and project portfolio, including lean projects.
• Is accountable for project management best practices.

Key Responsibilities & Accountabilities

Within the allocated geographical remit:

• To act as the first Quality point of contact for all New Product Introduction (NPI), market expansion and lifecycle management projects, ensuring:
  • Proper impact analysis across the Quality organization, planning of quality-related activities, execution, monitoring, and closure of projects (quality incl. compliance, time, cost).
  • Effective contribution to, and successful interaction with global Product Supply project management, regional/global NPI and cross-functional launch excellence teams.
  • Effective communication of information and knowledge, escalation, and decision-making.
  • Efficient coordination and resource allocation across the Quality teams
  • Risk assessment and mitigation plan execution where needed.
• To coordinate the development of and drive the execution of the department strategic/tactical roadmap, ensuring:
  • Alignment of project objectives with the company’s and division’s strategic goals.
  • Proper project selection and prioritization.
  • Efficient coordination, execution, and delivery (quality, time, cost).
  • Optimal resource allocation.
  • Adequate follow-up and reporting.  
• To develop and drive the department continuous improvement program, and foster the appropriate mindset across the organization through:
  • Identifying and quantifying any opportunity for efficiency improvement.
  • Developing and managing the continuous improvement roadmap.
  • Developing and coordinating the network of continuous improvement champions.
  • Ensuring related skills are developed and sustained across the organization.
  • Developing and implementing any enabling tool, system, process, or best practice.
  • Leveraging the use of data analytics and AI.
• To establish and maintain state-of-the-art project management and continuous improvement governance, standards, processes, best practices, and reporting, including knowledge management aspects (awareness, training, development, lessons learned…).
• To establish and maintain the department balanced score card, ensuring:
  • Appropriate metrics and targets are defined and monitored to drive performance up, anticipate problems and drive the right mindset.
  • All-time alignment with business goals and needs.
  • Best use of digital technologies so as to continually enable user-friendliness and efficiency.
• To ensure effective support and guidance is provided at all times to the organization on areas of expertise and responsibility.
• To manage the allocated budget, where required.

Qualifications

• Relevant degree and certifications (PMP/ PMI-ACP/ Scrum/ Agile/ Prince/ Lean-six-sigma Black/Green Belt)
• 10 years of industrial experience, of which at least 3 years in pharma or/and medical devices
• At least 5 years of cross-functional project