Overview
Director of Quality Jobs in Amsterdam Area at Prothya Biosolutions
Title: Director of Quality
Company: Prothya Biosolutions
Location: Amsterdam Area
Due to an internal promotion, we are looking for a new Quality Director for our production site in Amsterdam. As Quality Director, you are responsible for establishing, managing, and continuously improving our on-site quality processes, overseeing both Quality Assurance (QA) and Quality Control (QC) activities. You report directly to the VP Quality (Brussels/Amsterdam) and work closely with operational and technical teams to ensure that processes and products meet the highest cGMP standards. This role requires a strategic yet hands-on leader who can drive change and foster continuous process improvement.
Key Responsibilities
Strategic Quality Management
Developing and implementing a strategic quality policy that supports Prothya’s overall objectives. You set priorities and plan improvement initiatives that enhance compliance, efficiency, and operational excellence.
Oversight of QA and QC Activities
Leading both QA and QC departments with a strong focus on compliance with GMP guidelines. You manage and direct daily quality activities, ensure an optimal workflow, and support the resolution of quality-related issues.
Development of Processes and Structures
Driving the establishment of effective quality processes. You lead a team operating with limited automation and actively identify solutions to improve efficiency within a dynamic and sometimes challenging environment.
Stakeholder and Team Management
Motivating and coaching a diverse and growing team of QC and QA professionals (in total more than 100 FTE's). You play a key role in fostering a positive work environment and strengthening collaboration across departments and sites.
Audits and Inspections
Preparing for and leading internal and external audits, ensuring compliance with all European and US quality regulations (cGMP, ICH). You are responsible for maintaining relationships with external stakeholders and regulatory authorities.
Key Challenges
In this role, you will encounter several important challenges, including:
Team Development and Autonomy
The current team consists of both experienced and junior professionals. You support their professional development and encourage independence, which is essential in a dynamic environment requiring hands-on leadership.
Hands-On Leadership
The situation requires an engaged manager who is regularly present on the shop floor and actively contributes to resolving daily operational challenges.
Efficiency and Process Optimization
Due to a low level of automation, this role demands someone who can balance compliance with pragmatic solutions to increase productivity.
Balancing Compliance and Operational Excellence
You ensure strict adherence to quality standards while simultaneously enabling practical and efficient processes.
Your Profile
You are a strategic and results-driven leader with a strong eye for detail and proven experience in a highly regulated environment. In addition, you bring:
- An academic degree in a relevant field such as Chemistry, Biotechnology, or Pharmacy, preferably complemented by management training.
- At least 8–10 years of experience in the pharmaceutical or biotechnology industry, with demonstrated expertise in quality management and manufacturing processes, preferably experience with plasma-derived products.
- Extensive knowledge of GMP guidelines and international quality standards; experience with European and US regulations (ICH, FDA) is essential.
- Excellent communication skills in English, written and spoken.
- A hands-on mindset, a pragmatic approach, and experience initiating change management and process optimization initiatives.
- Strong analytical skills and decisiveness, with a proven track record in successfully leading and developing teams.
What Does Prothya Offer?
At Prothya Biosolutions, you will have the opportunity to be part of a driven team in a role with a direct impact on our quality standards.
We offer:
- A challenging and responsible position within an international and innovative organization.
- A competitive salary and attractive secondary benefits.
- Professional development opportunities and training to take your career to the next level.
- A culture where respect, diversity, and engagement are central.
