QA Validation Supervisor

Prothya Biosolutions; Brussel Hoofdstad; Hybrid; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Company car

Energy Card

Insurance

Training & development

Generous holiday package

Hybrid work option

International environment

Respect, diversity, collaboration

Job summary

Prothya Biosolutions is seeking a QA Qualification Supervisor to lead the QA Qualification team and ensure qualification and validation activities meet EU GMP and FDA standards. You will oversee quality records, provide expert QA guidance, and partner with internal stakeholders to enable timely release of pharmaceutical products.

The role requires a Master’s degree in a relevant field and a minimum of 3 years in a QA leadership position within life sciences.

Qualifications

• Master's degree in Chemistry, Biotechnology, Industrial Pharmacy, Pharmaceutical Sciences, or related field.
• Minimum 3 years of experience in a QA leadership role within pharma/lLife sciences.
• Fluent in Dutch, French, and English.
• Strong knowledge of EU GMP and FDA regulations.
• Proven people management and leadership skills.
• Excellent communication and stakeholder management abilities.

Responsibilities

• Lead QA Qualification team and ensure qualification/validation activities comply with EU GMP, FDA, and internal procedures.
• Oversee qualification and validation documentation; manage records and review/approve docs.
• Lead escalation meetings and support quality-related decision making.
• Participate in internal and customer audits and regulatory inspections; drive continuous improvement.
• Collaborate with Production, QC, Engineering, Maintenance, Logistics, and other departments to promote GMP compliance.

Skills

Dutch

French

English

EU GMP knowledge

FDA regulations

People management

Stakeholder management

Quality systems

Education

Master's degree in Chemistry/Biotechnology/Pharmaceutical Sciences

Job description

Make a difference in patients' lives worldwide.

At Prothya Biosolutions, we develop and manufacture life-saving plasma-derived medicines that improve the health of millions of patients worldwide. To support our continued growth, we are looking for an experienced QA Qualification Supervisor to lead our Quality Assurance Qualification team and ensure compliance with the highest pharmaceutical quality standards.

About the Role

As QA Qualification Supervisor, you will be responsible for managing, monitoring, and continuously improving the quality systems related to qualification and validation activities within Prothya Belgium.

You will lead a team of QA professionals and ensure that qualification and validation processes comply with internal procedures, EU GMP requirements, FDA regulations, and customer expectations, enabling the timely release of pharmaceutical products.

Key Responsibilities

Leadership & Team Management

• Lead, coach, motivate, and develop a team of 5 to 10 QA professionals.
• Organize departmental activities, workload planning, and task allocation.
• Monitor team performance and drive continuous improvement initiatives.
• Foster collaboration across departments and promote a positive working environment.

Quality Assurance & Compliance

• Ensure qualification and validation activities remain compliant, efficient, and up to date.
• Oversee quality records related to qualification, validation, and project activities.
• Review and approve qualification and validation documentation within agreed timelines.
• Act as a quality partner for internal stakeholders and provide expert guidance on QA systems.
• Chair escalation meetings and support quality-related decision-making.
• Support and participate in internal audits, customer audits, regulatory inspections, and follow-up activities.
• Promote GMP compliance throughout Manufacturing, QC, Engineering, Maintenance, Logistics, Warehouse, Supply Chain, and other operational departments.
• Represent QA during technical meetings with external customers and partners.

Project & Stakeholder Management

• Monitor QA-related project activities and ensure compliance throughout project lifecycles.
• Build strong relationships with key stakeholders across Production, QC, Engineering, Warehouse, Maintenance, OSD, and other departments.
• Drive a culture of quality, compliance, and continuous improvement.

What We're Looking For

Education

• Master's degree in Chemistry, Biotechnology, Industrial Pharmacy, Pharmaceutical Sciences, or a related scientific discipline.

Experience

• Minimum 3 years of experience in a similar QA leadership role within the pharmaceutical, biotech, or life sciences industry.
• Fluent in Dutch, French, and English.
• Strong knowledge of EU GMP, FDA regulations, and quality systems.
• Proven people management and leadership skills.
• Excellent communication and stakeholder management abilities.
• Strong analytical mindset with excellent organizational and prioritization skills.
• Customer-focused and able to influence and persuade effectively.
• Comfortable managing complex situations and working under pressure.
• Results-driven, detail-oriented, and proactive.

Why Join Prothya Biosolutions?

At Prothya, you will contribute to a meaningful mission: improving and saving lives through advanced plasma-derived therapies.

We offer:

• Competitive salary package
• Company car & unlimited Energy Card
• Group and hospitalization insurance
• Extensive training and development opportunities
• Attractive holiday package beyond statutory leave
• Hybrid working possibilities after successful onboarding
• An international, fast-growing biopharmaceutical environment
• A culture built on respect, diversity, innovation, and collaboration