Quality Director

Prothya Biosolutions; Amsterdam; On-site; EUR 120,000 - 180,000; Full time

Benefits offered by this job

Competitive salary

Attractive secondary benefits

Professional development opportunities

Job summary

Prothya Biosolutions, Amsterdam, is seeking a Quality Director to establish and lead on-site quality processes, overseeing QA and QC to meet cGMP standards. The role reports to the VP Quality and collaborates with operational and technical teams to drive change and continuous improvement.

You will shape the quality policy, direct daily activities, and manage a large team across sites, ensuring audits by European and US regulators (ICH, FDA) are passed and relationships with authorities are

Qualifications

• Academic degree in Chemistry, Biotechnology, or Pharmacy, preferably with management training.
• 8–10 years in pharmaceutical/biotech with quality management and manufacturing experience, preferably plasma-derived products.
• Extensive GMP knowledge and international quality standards; experience with European and US regulations (ICH, FDA) is essential.
• Excellent written and spoken English skills.
• Hands-on mindset with change management and process optimization experience.
• Strong analytical, decisive leadership and team development capabilities.

Responsibilities

• Strategic quality management to support overall objectives and plan improvement initiatives.
• Oversee QA and QC activities with focus on GMP compliance and efficient workflows.
• Develop and implement effective quality processes and structures in a low-automation environment.
• Lead and coach a large QC/QA team across sites, fostering collaboration and growth.
• Prepare for and lead internal and external audits, maintaining relations with regulatory authorities.

Skills

Quality management

GMP knowledge

Leadership

Analytical skills

Change management

English communication

Problem solving

Education

Academic degree in Chemistry, Biotechnology, or Pharmacy

Job description

Key Responsibilities

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.

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.

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.

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.