Associate Director - EU Qualified Person Commercial Products (IMP)

<p>BeiGene 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.</p><p></p><p></p><p><b><span>General Description:</span><span> </span></b><span> </span></p><p><span><span>The incumbent will report to the </span><span>Head </span><span>Commercial</span><span> Quality</span><span>.</span></span><span> </span></p><p><span><span>The Qualified Person Commercial Products certifying all manufacturing steps up to the finished product </span><span>is responsible for</span><span> ensuring that each finished medicinal product batch has been manufactured </span><span>in accordance with</span><span> GMP, the terms of the MIA (Manufacturing and Import Authorization), the MA (Marketing Authorization)</span><span> or made for export as per European Directive 2001/83/EC.</span></span><span> </span></p><p><span><span>Responsible for batch certification of commercial finished product for the EU and Rest of the World following Annex 16 of EU </span><span>regulation</span></span><span><span> </span></span><span><span>respectively</span><span>.</span></span><span> </span></p><p><span><span>Ideally also qualifies as a </span><span>Qualified Person for </span><span>Investigational Medicinal</span><span> </span><span>P</span><span>roducts and/or as </span><span>Responsible Person GDP </span><span>taking accountabilities according </span><span>EU GDP 2013/C 343/01.</span></span><span> </span></p><p><span> </span></p><p><b><span>Essential Functions of the job: </span></b><span> </span></p><p></p><p><b><span>Qualifications:</span></b></p><ul><li><span><span>Pharmacist/</span><span>MSc </span><span>or </span><span>Scientist </span><span>recognize</span><span>d</span><span> by Regulatory Aut</span><span>hority to </span><span>permit</span><span> Qualified Person (QP) </span><span>status as p</span><span>er</span><span> article 49 of Directive 2001/83/EC</span><span>.</span></span><span> </span></li></ul><ul><li><span><span>A minimum of </span><span>5</span><span> years of experience in the <span>healthcare/pharmaceutical</span> </span><span>industry </span><span>gained in </span><span>an</span><span> EMA </span><span>and FDA </span><span>approved pharmaceutical environment. Experience as a QP </span><span>in </span><span>pharmaceutical or biotech </span><span>industry. </span></span><span> </span></li></ul><ul><li><span><span>Solid foundation in Q</span><span>uality</span><span> and understanding of quality requirements through the whole value chain</span><span>.</span></span><span> </span></li></ul><p><b><span>Major responsibilities</span></b><b><span>:</span></b><span> </span></p><ul><li><p><span><span>Perform EU QP certification for </span><span>commercial </span><span>products under B</span><span>eiGene</span><span> responsibility</span><span>.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Ensure Quality Compliance with all National and International Regulations of the Authorities and internal </span><span>company </span><span>regulations.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Oversight of Quality Management System (QMS) which includes Quality Management Review, Quality Agreements.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Maintain QMS oversight as part of QP operational responsibilities (EU GMP Annex16)</span><span>.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Maintenance of the </span><span>Manufacturing and Import Authorization</span><span>s.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Providing guidance and integration of European and </span><span>other Health Authority</span><span> regulations</span></span><span> </span></p></li></ul><ul><li><p><span><span>Ensuring GMP knowledge of self and others within both the Quality team and other function</span><span>s</span><span> are kept up to date.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Participate as </span><span>required</span><span> in self-inspection activities and external audits</span><span>.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Host and support regulatory inspections, audits by clients / partners.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Input on quality policy, </span><span>objectives</span><span> and deliverables for business.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Focusing on the </span><span>m</span><span>anagement of authorized activities and the accuracy and quality of records.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Ensure maintenance of supply to the market</span><span>.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Perform GDP activities as </span><span>required</span><span>.</span>