Associate Director, External Supply Quality Europe

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.General Description: The Associate Director, External Supply Quality organization is responsible for ensuring that externally manufactured commercial products are manufactured, packed, labelled, stored and transported in a controlled way at Contract Manufacturing Organizations in accordance with the regulatory expectations and applicable GMP/GDP quality standards. The role has global responsibility and accountability for commercial product quality for global supply. The scope will also include product life cycle management projects. The job holder will support and ensure the compliance to applicable international regulations and BeOne quality standards and procedures at CMOs. The job location would be remote in Europe. The scope of the role will include but not limited to the following:Small molecule & Large Molecule commercial productsFor API, DP and FP Managing quality issues and changes at CMOsPost approval changes, packaging changes or other life cycle management projects, and clinical supply after commercializationThis role has hybrid work pattern, 3 days per week from Basel office with 2 days remote. Essential Functions of the Job: Lead Small Molecule commercial product quality team to ensure the quality management process is in place and executed to ensure the product quality is compliant with regulatory requirements and BeOne standards.Accountable for BeOne qualified CMO oversight within Europe including performance management, trend evaluations and remediation as required.Serve as the primary escalation point for CMO quality managersReview and approve change control strategy for CMO notified changesOversee and manage APQR activities for CMO manufactured BeOne productLead batch related deviation handling in investigation and effective CAPA implementation at CMOPerform PIP (Person in Plant)Oversee inspection management capabilities within the team to ensure successful outcomes for CMO hosted inspections or BeOne hosted inspections e.g. CMO PAIs, PV inspections.Ensure that quality processes meet Health Authorities expectation and continuously improve it by timely capturing related regulation changesAdvise and support Quality Agreement content, implementation, and updates.Will work cross functionally and collaboratively in BeOne with e.g. Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU.Responsible to ensure quality support on product commercial supply e.g. timely batch releaseSupport product recalls from commercial supply chain when neededPerform other tasks as assigned in accordance with SOPs, regulatory agencies and GxP guidelinesWork with Clinical Product Quality, regulatory and CMC to establish Process Performance Qualification for Small Molecule productsAuthor Standard Operating Procedures related to function and departmentSupervisory Responsibilities:  Responsible for management, development and co-ordination of a medium sized team of direct staff who are based in Europe.Accountable for financial control and for the management of related budgets such as headcount related and travel.Ensures sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency.Build talent pipeline by inspiring and encouraging team members and create a great place to work for their personal development and career success.6+ years of managerial experience directly managing people effectively.Ability to lead teams, manage staff, projects, programs and directing the allocation of resources.Computer Skills:Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).Other Qualifications:In-depth GMP experience in a quality and manufacturing function for small molecule and large molecules.Ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problemsTravel: May travel regionally and intercontinentally estimated up to 30%Global CompetenciesWhen 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.Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity