Senior Manager, EU Qualified Person Commercial Products

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

The Qualified Person (QP) Commercial Products, certifying all manufacturing steps up to the finished product level, is responsible for ensuring that each finished medicinal product batch has been manufactured and shipped in accordance with GMP, the terms of the MIA (Manufacturing and Import Authorization), the MA (Marketing Authorization) or made for export as per European Directive 2001/83/EC. Responsible for batch certification of commercial finished product for the EU and Rest of the World following article 28.1 Geneesmiddelenwet and Annex 16 of EU regulation respectively.

The incumbent will report to the Director, Distribution & Regional Quality, Europe Commercial Quality Head. Ideally also qualifies as a Responsible Person GDP taking accountabilities according EU GDP 2013/C 343/01.

• Perform EU QP certification for commercial products under BeOne responsibility for the products of BeOne Medicines I GmbH, Dutch Branch. Decisions regarding quality are taken by the QP independently. The QP carries out his/her direct supervision of activities according to the establishment license and has the decision power to take any action which is necessary to ensure compliance with the legal requirements.
• Oversight of Quality Management System (QMS) of QP operational responsibilities (EU GMP Annex 16, Annex 21).
• Ensure that all necessary steps have been completed according to the Quality Management System to assure compliance of batches with GMP, the MA and any other legal obligations in the Member State where certification is taking place.
• Maintenance of the Manufacturing and Import Authorization.
• Providing guidance and integration of European and other Health Authority regulations
• Ensuring GMP knowledge of self and others within both the Quality team and other functions are kept up to date.
• Participate in self-inspection activities and external audits as required.
• Support regulatory inspections, audits by clients / partners as required.
• Focusing on the management of authorized activities and the accuracy and quality of records.
• Ensure maintenance of supply to the market.
• Perform GDP activities as required.
• Support Product Complaints related investigation as necessary.
• Authorize recall in collaboration with Recall Committee.
• Support Deviations and Change Controls as necessary.
• Cooperate with all necessary departments to ensure that communication to the authorities is appropriate, coordinated and approved.

• None

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint), Veeva, SAP.
• Ability to work on a computer for extended periods of time.

• 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).

• Solid foundation in QA and understanding of product quality requirements through the whole value chain (globally).
• In-depth GMP experience in a quality and manufacturing function.
• Has an understanding of regulatory requirements linked to combination products and / or respective devices.

• In-depth knowledge of Quality principles, concepts, industry practices and standards.
• Working Knowledge and experience with Eudra Lex EU GMP Guidance, 21
  
  CFR
  210, 21
  
  CFR
  211, ICHQ7 as well as international regulations.
• Ability to work independently with scientific/technical personnel.
• Experience with regulatory compliance inspections.
• Apply principles of logical and scientific thinking to a wide range of intellectual and practical problems.
• Must possess good presentation skills to speak effectively before groups; ability to respond.
• Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail.
• Experienced with working cross-regions Supply Chain, Regulatory, and external service providers.

• Good Project Management Skill Set.
• Clear communication, sense of urgency and sensitive for the needs of the organization.
• Languages:
  
  Fluent in Dutch, English (C2), German is a plus.

• May travel occasionally.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial…