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- Define, implement, and facilitate phase-appropriate Quality Systems that represent the challenges and requirements associated with external oversight of manufacturing and testing operations (e.g. Change Control, Deviation, OOS, CAPA)
- Lead the scheduling, facilitating, and documenting Material Review Board (MRB) activities in alignment with internal procedures
- Lead and manage other key Compliance programs including but not limited to Raw Material Control Strategy, Supplier Quality Management, Quality Management Review, Quality Risk Management, and Product Quality Complaints
- Prepare and facilitate the periodic Quality Management Review (QMR) of Quality Systems performance, including assigning actionable continuous improvement efforts
- Represent CMC Quality on CARGO Commercial (Launch) Readiness team to ensure Quality Systems & Compliance programs are scalable, robust, and ready for commercialization
- As part of ensuring commercial readiness, partner with Head of QA Operations to ensure that CDMO(s) selected for commercial launch are inspection-ready with key compliance gaps identified and remediated per established plans
- In partnership with Clinical Quality, harmonize, lead, and manage Inspection Readiness program/process for CARGO
- Develop/own associated QMS procedures and ensure training is available for applicable CARGO personnel
- Manage/maintain supplier qualification program for critical GxP vendors (e.g. CMOs, CTLs, Shipping, Storage, 4PL, etc.)
- Lead internal planning/preparation of supplier audits (qualification, routine, for cause) and, when applicable, regulatory inspections (e.g. BIMO, CMO, etc.)
- Support data verification/review activities for Module 3 content for IND/BLA filings as assigned
- Lead and/or support cross functional teams to perform root cause analysis and thorough quality investigations
- Provide technical support and compliance oversight to the GxP Documentation and Training Administration programs
- Support implementation and maintenance of Data Integrity processes
- Partner closely with Head of Quality Control to fully support associated Quality Systems and ensure compliance within Quality Control processes
- Ensure any key procedures/processes not yet developed are identified and implemented to ensure ongoing compliance
- Monitor regulatory changes and guidance documents, ensure implementation of new and/or changes to legal and regulatory requirements; ensure policies and procedures are updated to remain in compliance with those applicable requirements
- Responsible for the oversight of processing and documented resolution of all product quality complaints and adverse events
- Support Lot Disposition process as required
- Bachelor's degree or higher in life science in biology, biochemistry or any related technical discipline
- Minimum 12-15 years' relevant experience in a regulated biotechnology, pharmaceutical company with progressive levels of responsibility, and experience leading and managing teams
- Strong working knowledge of cGMP, including ability to interpret and apply ICH guidance and regulatory guidance
- Experience working with external manufacturing partners
- Experience setting up quality systems (preferred) and interacting with electronic quality systems (e.g Veeva, Trakcel)
- Proven ability to work effectively in a fast-paced team environment
- Success troubleshooting complex manufacturing investigations combining understanding of manufacturing operations with technical, compliance, quality and regulatory considerations working with cross functional teams
- Strong technical foundation in biologics or cell/gene therapy manufacturing process and technology
- Ability to effectively communicate complex quality content to a range of audiences in oral and written formats
- Ability to flex between hands-on work (example: day-to-day Quality support) and at the same time strategic work (example: planning/projecting future workload, and proactive risk mitigations working cross functionally)
- Knowledge of basic GMPs and regulatory requirements applicable to cell and gene therapy
- Experience working with viral vector and cell therapy processes
- Direct or indirect supervisory experience leading small teams
- Experience working external CDMO relationships as well as working in internal manufacturing operation
- Proficient with Veeva, MS-Word, Excel, Lucidchart, Powerpoint, SharePoint, Slack, and Smartsheet
Director, Quality Systems - San Carlos, United States - Cargo Therapeutics
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