- 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
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Director, Quality Systems - San Carlos, United States - Cargo Therapeutics
Description
CARGO Therapeutics is hiring a Director of Quality Systems & Compliance within the CMC Quality function of the Technical Operations business unit. Reporting to the Senior Director of Quality Assurance & Systems, this is a key role focused on building and managing a phase-appropriate Quality Systems & Compliance program in support of global manufacturing, testing, and distribution of clinical and commercial CAR T products. Given that we are an early-stage company, this a key role within the overall Quality organization and as such is a great opportunity to be part of setting the Quality culture and making a lasting impact.
The role can be Remote or located at Headquarters in San Carlos, CA.
WHAT YOU'LL DO AT CARGO THERAPEUTICS
Key responsibilities of the Director of Quality Systems & Compliance will broadly include these elements:
The combined pay range for this role is $171,000 - $235,000. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.
ABOUT CARGO THERAPEUTICS
CARGO Therapeutics, Inc. is a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients. CARGO's programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply. CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies. Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic "cargo" designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion. CARGO's founders are pioneers and world-class experts in CAR T-cell therapy, and its team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at https://cargo-
Join us to help make a difference
EEO & EMPLOYMENT ELIGIBILITY
CARGO Therapeutics, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. CARGO Therapeutics, Inc. also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification required of applicable law.
CARGO Therapeutics requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at CARGO Therapeutics, and it applies regardless of whether the position is located at a CARGO Therapeutics site or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
