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CMO Quality Manager

Company: Seattle Genetics, Inc.
Location: Bothell
Posted on: February 16, 2020

Job Description:

Summary: Provide Quality and Compliance oversight for Seattle Genetics products manufactured at Contract Manufacturing Organizations (CMOs) to ensure compliance with cGMP regulations and quality agreement, including small and large molecules intermediates, drug substance, and drug product. Serve as the Quality Single Point of Contact (SPoC) for designated CMO(s) and participate as a key member of CMO governance teams to enable (as applicable for the CMO lifecycle stage) site selection and implementation (including due diligence activities), on-going quality supply from CMO sites, and/or decommissioning. Principal Responsibilities: Develop, negotiate and maintain Quality Agreements with CMO and ensure compliance with agreements Manage all required activities to support production including approval of master production documentation, batch record review qualification of CMO, resolution of investigations, assessment of change controls, and monitor and report CMO quality performance Perform Technical Disposition of clinical/commercial products Hold CMO accountable for maintaining the manufacturing processes and the Specifications and Analytical Methods in a validated state and compliant with the regulatory dossier Oversee complex investigations in partnership with CMO and report to SGEN Deviation/Material Review Board and CMC teams Develop/maintain quality risk management plans; utilize risk management tools to identify and mitigate CMO quality and compliance risks, ensuring CMO sites are in a state of continuous inspection readiness Provide as needed support during regulatory inspections and cGMP compliance audits, collaborating with CMOs to ensure on time closure of associated CAPAs when requested Ensure that CMO provides Annual Product Quality Reviews, product complaint investigations and other quality GMP documents in a timely manner following expectations set forth in the Quality Agreement Hold CMO accountable and address gaps of audit responsiveness, CAPA implementation, deviation reporting and management, investigation closure, and change implementation with regards to quality and time with the CMO; and escalate as appropriate Monitor and assess External Suppliers' key performance indicators to propose Continuous Improvement initiatives Collaborate and manage relationships across CMO management and internal governance teams to assure quality expectations are aligned and support joint improvement goals Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance Troubleshoot and direct the resolution of quality issues, fostering effective interdepartmental and cross-functional partnerships Sign documents as authorized and described by Seattle Genetics policies, procedures and job descriptions Review and approve process validation protocols and reports Set personal performance goals and provide input to departmental objectives Maintain and communicate work priorities to meet goals and timelines. Complete all job-related training while striving to continuously improve on knowledge and skills in quality, compliance and technology Communicate new and updated regulatory requirements and applicable Seattle Genetics expectations to CMO, as applicable, and evaluate systems in place Qualifications: A thorough knowledge and appropriate application of GMPs and other regulations applicable to U.S. and international regulatory agencies Must be capable of assessing compliance to quality requirements using sound judgement and decision-making skills Experience in managing and working with CMOs Excellent verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills are essential Experience auditing CMOs desirable Innovative, proactive, and resourceful; committed to Quality and continuous improvement Ability to travel domestically and internationally 20% of time 12+ years relevant GMP Experience Education: BS/BA or Masters Degree in a relevant field As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. #LI-DD1

Keywords: Seattle Genetics, Inc., Seattle , CMO Quality Manager, Other , Bothell, Washington

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