Current jobs related to Associate Director, DP Commercial Small Molecule - Emeryville - BeiGene
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Emeryville, United States BeiGene Full time**General Description:**The Associate Director, DP Commercial Small Molecule in External Supply Quality organization is responsible for ensuring the commercial small molecule products are manufactured, packed, labelled, stored and transported in a controlled way at CMOs that is in accordance with the regulatory expectations and applicable GMP/GDP quality...
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Emeryville, California, United States BeiGene Full timeJob SummaryThe Senior Quality Director, Commercial Small Molecule will lead the quality management process for commercial small molecule products, ensuring compliance with regulatory requirements and BeiGene standards. This role will oversee the quality team, manage quality issues, and implement effective CAPA processes.Key ResponsibilitiesLead the quality...
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Emeryville, California, United States BeiGene Full timeJob Summary:The Associate Director, DP Commercial Small Molecule role at BeiGene is responsible for ensuring the commercial small molecule products are manufactured, packed, labelled, stored and transported in a controlled way at Contract Manufacturing Organizations (CMOs) that is in accordance with the regulatory expectations and applicable Good...
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Associate Director, DP Commercial Small Molecule
2 months ago
General Description: The Associate Director, DP Commercial Small Molecule in External Supply Quality organization is responsible for ensuring the commercial small molecule products are manufactured, packed, labelled, stored and transported in a controlled way at CMOs that is 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 like dosage form changes, packaging changes and clinical supply after commercialization. The job holder will support and ensure the compliance to applicable international regulations and BeiGene quality standards and procedures at CMOs. The job location would be in US so that close to where CMOs are based. The scope of the role will include but not limited to the following, Small molecule commercial products For DP and FP stages at CMO Managing quality issues and changes at CMOs Post approval dosage form changes, packaging changes or other life cycle management projects, and clinical supply after commercialization 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 BeiGene standards. Perform batch record review Lead batch related deviation handling in investigation and effective CAPA implementation at CMO Manage change controls Perform batch dispositions Perform PIP (Person in Plant) Prepare batch related documents e.g. COA Manage temperature excursion from storage and transportation. Ensure that quality processes meet Health Authorities expectation and continuously improve it by timely capturing related regulation changes Advise and support Quality Agreement content, implementation, and updates. Obtain quality performance information at CMOs and drive continuous improvement. Provide the performance metrics information to CMO vendor management team and escalate any quality or compliance issue timely to senior management when needed. Closely collaborate with the CMO Vendor Management team on vendor performance monitoring and periodic review, support in audits as required Will work cross functionally and collaboratively in BeiGene with e.g. Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU. Provide quality support on product commercial supply e.g. timely batch release Support GCP inspections in IMP manufacturing perspective Execute product recalls from commercial supply chain when needed Perform other tasks as assigned in accordance with SOPs, regulatory agencies and GxP guidelines Work with Clinical Product Quality, regulatory and CMC to establish Process Performance Qualification for Small Molecule products Author Standard Operating Procedures related to function and department Oversee the following investigations: nonconforming product, customer complaint, laboratory OOS and CAPA. Ensure all investigations are performed and closed in timely fashion Supervisory Responsibilities: Responsible for management, development and co-ordination of a medium sized team of direct staff who are based in US 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. Computer Skills: Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint) Qualifications: Bachelor of Science degree or above, in a related scientific discipline/technical filed such as Pharmacy, Biology, Chemistry or Engineering Minimum 8 years pharmaceutical or biotechnology industry experience. 8+ years of experience in quality with above 6 years management experience In-depth GMP experience in a quality and manufacturing function for small molecule oral solid dosage forms at DP and FP stages Ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems Ability to effectively lead teams and manage staff Travel: May travel regionally and intercontinentally estimated up to 30% All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
