Quality Control Lead, Global Quality Control Microbiology

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We are seeking a highly motivated, experienced, and key opinion leader with a demonstrated track record leading initiatives in a GMP manufacturing environment for the role of QC Lead, Global QC Microbiology.  This position will report to the Director of Global QC Microbiology and will focus on projects, process, and goals aimed at alignment across our expanding global operations.

In this role, you will support the advancement of the Corporate Microbiology Center of Excellence with focused expertise in microbiology, aseptic processing, and sterility assurance to guide Kite and guide Regulators. Additionally, you will work closely with the Global QC Micro team to drive the strategic direction for the site Microbiology QC teams across our Global QC network, comprehensively understand and educate regarding technology capabilities and detection, and advance introduction of creative approaches and/or appropriate methodologies to position Kite as the leader in this field.

As importantly, you will collaborate closely with our network of Kite manufacturing sites around the globe, to rapidly investigate issues related to bioburden control of our process, how we control when issues arise during manufacturing, and publish ‘position papers’ to guide the industry and scientific community.  You will also utilize quality resources such as lean, six sigma, risk management, and other risk-based tools to continually improve quality operations.

Responsibilities:

• Serve as a key representative in all areas of Microbiology across global QC network and various stake-holder teams
• Ensure proper quality skill sets and competencies are consistent with business and technology plans.
• Support the development and implementation of the annual microbiology roadmap including the planning and execution microbiology specific goals, action plans, and budgets.
• Thorough knowledge and expertise in aseptic processing and microbiology.
• Develop ‘forward thinking’ strategy for routine microbial analysis, Environmental Monitoring (EM) program, and raw material/growth promotion testing.
• Work with peer groups to establish user requirements for purchase, qualification of Kite’s QC microbiology equipment.  Work with internal and external resources to maintain equipment in an optimal state.
• Develop appropriate and comprehensive QC Microbiology and Aseptic Techniques Training programs.
• Manage method transfers to/from contract testing labs and Kite facilities as appropriate.
• Quality metric reporting to executive management through Management Review process, including gathering metric information for use in continuous improvement of areas of responsibility.
• Collaborate with product sciences, manufacturing, translational sciences, engineering, and clinical groups.
• Oversee review and approval of process and method validation, qualifications, and validation reports, change control documents, and technical reports.
• Draft and review appropriate sections of BLA, IND.
• Prepare dossiers and data packages for interactions between Kite and Regulatory agencies.  Interact with agents from Regulatory agencies, participate in Pre-Approval Inspections, defend regulatory audits and draft responses.
• Monitor the GMP systems currently in place to ensure compliance with documented policies.
• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.

Basic Qualifications:

• PhD and 2+ years of experience in a GMP environment in the biological sciences or related field OR
• Masters Degree and 8+ years of experience in a GMP environment in the biological sciences or related field OR
• Bachelor's Degree and 10+ years of experience in a GMP environment in the biological sciences or related field OR
• High School Diploma/GED and 14+ years of experience in a GMP environment in the biological sciences or related field

Preferred Qualifications:

• Extensive working knowledge of quality system and regulatory requirements such as US FDA GMP, GCP, EMA, and ICH guidelines, and demonstrated experience of successfully implementing these requirements.
• Knowledge of fundamental microbiological principles and structured problem solving with focused expertise in microbiology, aseptic processing, sterility assurance, bioburden control of processes, and how to control when issues arise in manufacturing.
• Demonstrated ability to successfully interact with regulatory health authorities at inspections.
• Excellent knowledge of technical writing for BLA, MAA, IND.
• Ability to write up technical assessments and that use modern risk management methodology.
• Ability to lead and guide cross functional employees to ensure compliance.
• Ability to effectively present information in small and large group situations to staff, customers, regulators, and executive management.
• Demonstrated ability to engage, lead, and motivate a large and diverse group of Quality professionals in a fast-paced environment and able to adjust workload based upon changing priorities.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
• Excellent interpersonal, verbal, and written communication skills essential.
• Proficient in MS Word, Excel, Power Point, Visio, Project, and statistical software.

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