Senior Quality Assurance Manager
Vor 6 Tagen
BeiGene is seeking an experienced Associate Director to join our team. As a key member of our Commercial Quality team, you will be responsible for ensuring the quality and compliance of our commercial products.
Key Responsibilities:- Perform EU QP certification for commercial products under BeiGene responsibility.
- Ensure Quality Compliance with all National and International Regulations of the Authorities and internal company regulations.
- Oversight of Quality Management System (QMS) which includes Quality Management Review, Quality Agreements.
- Maintenance of the Manufacturing and Import Authorizations.
- 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 as required in self-inspection activities and external audits.
- Host and support regulatory inspections, audits by clients / partners.
- Input on quality policy, objectives and deliverables for business.
- 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.
- Ensure that all necessary steps have been completed according to the Quality Management System to assure compliance of the batch with GMP, the MA and any other legal obligations in the Member State where certification is taking place.
- Participate in Quality Management Reviews of applicable Manufacturing sites and Global Supply Chain Management Review.
- Where applicable provide requirements for Manufacturing sites to be reflected in respective Quality Agreements
- Ensure that suppliers and customers are approved in coordination with responsible departments. Approve any subcontracted activities, which may impact on GMP.
- Host GMP Health Authority Inspections; responsible for readiness, preparation and coordination.
- Host internal Audits and coordinate follow up.
- Lead and coordinate Self-Inspection program including risk management.
- Responsible for GMP Service Providers qualification and monitoring.
- Support Product Complaints related investigation as necessary.
- Authorize recall in collaboration with Recall Committee.
- Cooperate with all necessary departments to ensure that communication to the authorities is appropriate, coordinated and approved.
- 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 5 years of experience in the healthcare/pharmaceutical industry gained in an EMA and FDA approved pharmaceutical environment. Experience as a QP in pharmaceutical or biotech industry.
- Solid foundation in Quality and understanding of quality requirements through the whole value chain.
- Clear communication, sense of urgency and sensitive for the needs of the organization.
- Ability to work on a computer for extended periods of time.
May travel occasionally.
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- 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 Excellence
- Communicates with Clarity
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