Associate Director - GVP Quality Lead EMEA

<p>BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. 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.</p><p></p><p></p><p><b>General Description: </b></p><p></p><p>The GVP Quality Lead, is responsible for supporting the Director GVP Quality in implementing and maintaining a balanced, proactive, global approach to GVP Quality Assurance. This position will be primarily responsible for ensuring PV activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards, procedures and practices.</p><p></p><p><b>Essential Functions of the job: </b></p><ul><li>Conduct and support quality assurance (QA) activities related to applicable PV regulatory requirements, guidelines, laws and internally established standards, procedures and practices for all phases of drug development</li><li>Participate and support as member of the GVP QA team to enhance performance and maintain accountability for the implementation of QA systems</li></ul><ul><li>Develop/improve and manage quality systems and processes to include:</li></ul><ul><li>Conducting/managing routine/for cause audit of vendors, partner, internal audits etc.</li><li>Supporting the activities related to the vendor management process training, SOPs, etc.</li><li>Maintaining Key QA systems, such as investigations, Significant Quality Events (SQEs), Deviations, CAPAs, Audits</li><li>Developing and managing Integrated Quality Management Risk plans</li><li>Conducting/managing review of key PV documents</li><li>Developing quality metrics and measures to drive assessment and continuous improvement</li><li>Management and review of trends and report significant <span><span>investigation/deviation</span></span> issues and system deficiencies to senior management, as appropriate</li><li>Coordinate and/or administer GCP/GVP training, as needed</li><li>Participate in the review of metrics (i.e. deviation, etc.) as part of Quality Management Risk approach to identify gaps, trends and the need for process improvements</li></ul><ul><li>Coordinate and support PV inspection readiness activities and contribute to regulatory health authority inspections conduct and management</li></ul><ul><li>Expert knowledge of GVP requirements</li><li>Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment</li><li>Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance</li><li>Strong global knowledge and understanding of international PV regulations applicable to the conduct of clinical trials and pharmacovigilance operations</li><li>Participate and represent R&amp;D Quality in meetings and discussions, as needed</li></ul><ul><li>Other duties as assigned</li></ul><p></p><p><b>Qualifications: </b> </p><ul><li>Bachelor’s degree, preferably in Science</li><li>Expert knowledge of GVPs and GCP requirements</li><li>Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors</li><li>Promote continuous improvements in quality systems and department infrastructure; assist with creation / revision of appropriate SOPs</li><li>Proven ability in driving quality process improvement initiatives</li><li>Strong global knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operations</li><li>Excellent English oral &amp; written</li></ul><p></p><p></p><p></p><p></p><p></p><p><u><span>Global Competencies</span></u></p><p>When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.</p><ul><li>Fosters Teamwork</li><li>Provides and Solicits Honest and Actionable Feedback</li><li>Self-Awareness</li><li>Acts Inclusively</li><li>Demonstrates Initiative</li><li>Entrepreneurial Mindset</li><li>Continuous Learning</li><li>Embraces Change</li><li>Results-Oriented</li><li>Analytical Thinking/Data Analysis</li><li>Financial Excellence</li><li>Communicates with Clarity</li></ul><p></p><p></p><p>We are proud to be an equal opportunity employer and we value diversity. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disabili