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Manager, External Quality Operations
vor 2 Wochen
Position Summary:
Principal Responsibilities:
- Serve as Quality Single Point of Contact on one or more internal Virtual Management Teams consisting of Technical Development, Quality, Planning, Logistics, and Manufacturing Sciences & Technology representatives
- 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
- Support 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
- Accountable for inspection readiness of the CMOs. 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
- Lead investigation at the CMO with SeaGen cross-functional team support
- Support the Product Quality Lead in the review of the regulatory dossiers
- Monitor and assess External Suppliers’ key performance indicators to propose Continuous Improvement initiatives
- 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
- 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 SeaGen 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.
- Support new hired on boarding with dedicated training on the job
- Support investigations connected with Product Complaints and Recalls/Mock Recalls
- 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 Seagen expectations to CMO, as applicable, and evaluate systems in place
- Ensure that CMOs make available data for process monitoring purpose as requirement for the CPV activities at Seagen
Qualifications:
- Minimum of Bachelor’s degree in a scientific discipline (Chemistry, Microbiology, etc.) - 8/12+ years experience in the pharmaceutical industry
- Ability to travel domestically and internationally 20% of time
- 8/12+ years relevant GMP Experience
- thorough understanding of local compliance, as well as a sound ethical approach to business
- 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
- Innovative, proactive, and resourceful; committed to Quality and continuous improvement
- Experience auditing CMOs desirable
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