
Senior Quality Engineer I, Global Quality Control
United States - Maryland - FrederickQualityRegularОписание вакансии
Kite is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies. We have two commercial products, Yescarta® and Tecartus®, along with a robust pipeline of various autologous and allogeneic clinical programs.
Kite is seeking a highly motivated individual to join the Global Quality Control team to provide oversight of the method development and implementation of GQC systems supporting the testing programs at Kite.
Reporting to the Director of Global QC, in this role you will develop and be responsible for Kite’s approach to test method validation, system qualification and commissioning, automation integration, and computer system validation. Additionally, you will collaborate closely with our network of QC laboratories, Process Development, Quality and Regulatory organizations around the globe to provide strategic direction aimed at guiding, educating, and influencing the different stakeholder groups to ensure all sites remain up to date with current industry guidance and best practices.
Responsibilities:
- Provide oversight and support of the method validation requirements to maintain an extensive program that is compliant with current and emerging guidance.
- Provide Quality Engineering oversight for Automation and Computer Systems as well as Commissioning, Qualification, and Validation related activities.
- Represent Global QC in cross-functional stakeholder teams motivating strategic alignment on method performance, technology automation and optimization, and compliance requirements
- Serve as primary support for the change control process for validated systems.
- Support the cross functional system owners with strategic quality oversite and input with CQV deliverables.
- Guides efforts/teams focused on identifying primary root causes and implements corrective and preventative actions to ensure minimal errors/issues.
- Guides and demonstrates compliance with agency regulations/guidance and standard operating procedures regarding computerized system validation, automated system implementation, and risk management.
- Actively collaborates with external service providers and internal management to ensure compliance with regulations.
- Uses advanced statistical techniques for data analysis. Uses complex research techniques and methodologies such as six sigma and kaizen to improve QE processes and procedures.
- Proactively recommends and implements improvements to automated processes, and related document templates.
- Support the Risk Management Program to evaluate and mitigate risks associated with laboratory equipment, systems, and functional programs as appropriate using resources such as Failure Modes Effects and Analysis (FMEA), Fault Tree Analysis (FTA) or other available risk management tools
Basic Qualifications:
- Master’s Degree and 4+ years of GXP experience in the biotech and/or pharmaceutical industry specific to compendial microbiology assays for testing of raw materials and excipients OR
- Bachelor’s Degree and 6+ years of GXP experience in the biotech and/or pharmaceutical industry specific to compendial microbiology assays for testing of raw materials and excipients OR
- High School Degree and 10+ years of GXP experience in the biotech and/or pharmaceutical industry specific to compendial microbiology assays for testing of raw materials and excipients
Preferred Qualifications:
- Direct experience with Gene/Cell therapy products for clinical and/or commercial method validation and technical transfer of assays
- Detailed knowledge of industry technology supporting the QC lab space.
- Extensive knowledge of Quality Management System (QMS) records and ability to serve as record owner, driving to completion.
- Extensive knowledge of regulatory guidance and industry best practices
- Developing, monitoring, and presenting KPIs related to the Quality network.
- Must demonstrate effective organizational skills and ability to manage multiple projects.
- Must have demonstrated experience analyzing and interpreting technical results and summarizing these results in technical reports.
- Proficiency in concept, deployment and support of computerized systems.
- Proficiency in process automation across the commercialization of pharmaceutical/biotech products.
- Thorough experience with global automation compliance requirements.
- Excellent knowledge of GMP, GAMP, SOPs and quality systems.
- Demonstrates in-depth knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is beneficial.
- Demonstrates knowledge of Risk Management resources (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)).
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