Position: Qualified Person (QP) / Senior Quality Assurance Manager (M/F/D)
Location: Brussels
About the Role:
We are seeking a Qualified Person (QP) / Senior Quality Assurance Manager to lead quality and compliance efforts related to Good Distribution Practice (GDP) in Brussels, supporting multiple healthcare markets. This role is essential in ensuring that products are distributed in compliance with applicable regulations and global quality standards.
Key Responsibilities:
Serve as the Qualified Person (QP) under Belgian Medicinal Products Law.
Act as the Responsible Person (RP) for Distribution in the Belgium.
Certify each batch before release or export and maintain the certification register.
Manage quality agreements and documentation for all manufacturing, testing, and distribution activities.
Audit and qualify vendors to ensure compliance with GMP/GDP and marketing authorizations.
Handle quality incidents, product complaints, and recalls, and liaise with regulatory authorities as needed.
Prepare for and lead inspections by regulatory bodies.
Approve and oversee annual training plans, ensuring staff are properly trained and qualified.
Investigate deviations and implement corrective and preventive actions (CAPAs).
Monitor and report on Quality Indicators to drive continuous improvement.
Qualifications:
Education: Masters Degree in Pharmacy.
Registration: Registered and approved as a QP by Belgian Authorities.
Experience:
At least 1 year of experience as a Qualified Person under supervision.
Minimum 2 years of experience in Quality Assurance.
Knowledge:
Advanced understanding of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
Fluent in Dutch, French and English.
Skills:
Strong communication, stakeholder management, and organizational abilities.
What We Offer:
A dynamic and supportive work environment that values purpose, innovation, and work-life balance.
Opportunities for mentorship and professional development through formal training and feedback.
A competitive salary and benefits package with regular performance reviews and potential promotions.
This role offers a unique opportunity to ensure the quality and compliance of healthcare products in a respected, growing organization. If youre ready to make an impact, wed love to hear from you!