Senior Manager, EU Qualified Person – Commercial Products
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: Netherlands
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Job Level
About the role
- Perform EU QP certification for commercial products under BeOne responsibility for the products of BeOne Medicines I GmbH, Dutch Branch.
- Ensure compliance with legal requirements and oversee QMS of QP operational responsibilities.
- Maintain Manufacturing and Import Authorization and ensure GMP knowledge within the team.
- Participate in audits and inspections, ensuring accuracy and quality of records.
- Support regulatory inspections and manage authorized activities.
- Authorize recalls and cooperate with necessary departments for communication with authorities.
Requirements
- Pharmacist/MSc or Scientist recognized by Regulatory Authority to permit Qualified Person (QP) status as per article 49 of Directive 2001/83/EC.
- A minimum of 3 years of experience in the healthcare/pharmaceutical/biotechnology industry gained in a European approved pharmaceutical environment.
- Experience as a QP in pharmaceutical or biotech industry (which includes an understanding of pharma/biotech manufacturing as well as Quality Control Activities).
- In-depth GMP experience in a quality and manufacturing function.
- An understanding of regulatory requirements linked to combination products and/or respective devices.
- Fluent in Dutch, and English (C2); German is a plus.
Benefits
- Equal opportunity employer
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
EU QP certificationGMP knowledgeQuality Control ActivitiesManufacturing AuthorizationImport AuthorizationRegulatory inspectionsAudit participationRecord accuracyRecall authorizationCompliance oversight
Soft Skills
CommunicationTeam collaborationAttention to detailProblem-solvingLeadership
Certifications
Pharmacist/MScQualified Person (QP) status