Senior Manager, Quality Control

About the role

The Senior Manager, Quality Control will play a critical role in designing, developing, and executing the operational readiness program for the start-up of the Quality Control laboratories at the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford, NC. You will lead and enable the timely completion of key milestones to ensure production targets are achieved. This role will initially work in a greenfield environment and will transition to lead laboratory operations throughout GMP readiness, technology transfer, and facility licensure activities supporting the manufacturing of Phase III and early commercial products.

Responsibilities

• Provide technical leadership, collaborating cross-functionally in the site's early-stage activities, including: facility detailed design review; facility, equipment, and analytical instrument user requirements review; prioritization for implementation of equipment, instruments, and analytical methods required for facility start-up (GMP Ready/OQ Complete); and ICT efforts for developing user requirements and procuring selected electronic Quality Systems for operations (LIMS/ELN/Empower).
• Establish and maintain Quality Control procedures as applicable to the Site QMS Laboratory Controls Sub-system and develop training requirements for QC staff.
• Lead and coordinate, cross-functionally, the robust, compliant, and timely implementation of all required analytical and microbiological test methods by ensuring completion of the required steps from method development, qualification/optimization, validation, or suitability for compendial methods and/or transfer.
• Establish a Raw Materials sampling, testing, and release program in compliance with all applicable regulatory requirements (JP, USP, EP, etc.).
• Carefully coordinate testing and reporting of laboratory results in support of the facility Environmental Monitoring and Utility Monitoring programs.
• Lead QC laboratory operations to achieve all required validation and qualification activities for the facility, equipment, analytical instruments, and computerized systems required for project commissioning and operational readiness for start-up.
• Ensure laboratory electronic systems and records are compliant with current 21 CFR Part 11 and Data Integrity (ALCOA++) requirements.
• Hire, onboard, train, and mentor QC staff per approved staffing plans.
• Lead and ensure the timely investigation of deviations, laboratory exceptions, or other cGMP issues at the site and initiate and communicate corrective and preventive actions (CAPA) for resolution, working cross-functionally.
• Establish key performance indicators for the QC laboratories (e.g., OOS, Invalid Assays, OOT, Laboratory Deviations, Testing Turnaround Times, EM Data Trends, etc.).
• Implement and manage the Contamination Control Strategy (CCS) for the site, working cross-functionally.
• Absorb and assist the Quality Site Head in identifying and qualifying contracted laboratory services and/or contingent staffing as required (Disinfectant Efficacy Studies, Mycoplasma, in vitro adventitious virus testing).
• Lead QC laboratory activities required to successfully respond to regulatory requests and support regulatory and internal inspections of the facility and laboratory areas.

Requirements

• Provide technical leadership, collaborating cross-functionally in the site's early-stage activities, including: facility detailed design review; facility, equipment, and analytical instrument user requirements review; prioritization for implementation of equipment, instruments, and analytical methods required for facility start-up (GMP Ready/OQ Complete); and ICT efforts for developing user requirements and procuring selected electronic Quality Systems for operations (LIMS/ELN/Empower).
• Establish and maintain Quality Control procedures as applicable to the Site QMS Laboratory Controls Sub-system and develop training requirements for QC staff.
• Lead and coordinate, cross-functionally, the robust, compliant, and timely implementation of all required analytical and microbiological test methods by ensuring completion of the required steps from method development, qualification/optimization, validation, or suitability for compendial methods and/or transfer.
• Establish a Raw Materials sampling, testing, and release program in compliance with all applicable regulatory requirements (JP, USP, EP, etc.).
• Carefully coordinate testing and reporting of laboratory results in support of the facility Environmental Monitoring and Utility Monitoring programs.
• Lead QC laboratory operations to achieve all required validation and qualification activities for the facility, equipment, analytical instruments, and computerized systems required for project commissioning and operational readiness for start-up.
• Ensure laboratory electronic systems and records are compliant with current 21 CFR Part 11 and Data Integrity (ALCOA++) requirements.
• Hire, onboard, train, and mentor QC staff per approved staffing plans.
• Lead and ensure the timely investigation of deviations, laboratory exceptions, or other cGMP issues at the site and initiate and communicate corrective and preventive actions (CAPA) for resolution, working cross-functionally.
• Establish key performance indicators for the QC laboratories (e.g., OOS, Invalid Assays, OOT, Laboratory Deviations, Testing Turnaround Times, EM Data Trends, etc.).
• Implement and manage the Contamination Control Strategy (CCS) for the site, working cross-functionally.
• Absorb and assist the Quality Site Head in identifying and qualifying contracted laboratory services and/or contingent staffing as required (Disinfectant Efficacy Studies, Mycoplasma, in vitro adventitious virus testing).
• Lead QC laboratory activities required to successfully respond to regulatory requests and support regulatory and internal inspections of the facility and laboratory areas.

Qualifications

• Provide technical leadership, collaborating cross-functionally in the site's early-stage activities, including: facility detailed design review; facility, equipment, and analytical instrument user requirements review; prioritization for implementation of equipment, instruments, and analytical methods required for facility start-up (GMP Ready/OQ Complete); and ICT efforts for developing user requirements and procuring selected electronic Quality Systems for operations (LIMS/ELN/Empower).
• Establish and maintain Quality Control procedures as applicable to the Site QMS Laboratory Controls Sub-system and develop training requirements for QC staff.
• Lead and coordinate, cross-functionally, the robust, compliant, and timely implementation of all required analytical and microbiological test methods by ensuring completion of the required steps from method development, qualification/optimization, validation, or suitability for compendial methods and/or transfer.
• Establish a Raw Materials sampling, testing, and release program in compliance with all applicable regulatory requirements (JP, USP, EP, etc.).
• Carefully coordinate testing and reporting of laboratory results in support of the facility Environmental Monitoring and Utility Monitoring programs.
• Lead QC laboratory operations to achieve all required validation and qualification activities for the facility, equipment, analytical instruments, and computerized systems required for project commissioning and operational readiness for start-up.
• Ensure laboratory electronic systems and records are compliant with current 21 CFR Part 11 and Data Integrity (ALCOA++) requirements.
• Hire, onboard, train, and mentor QC staff per approved staffing plans.
• Lead and ensure the timely investigation of deviations, laboratory exceptions, or other cGMP issues at the site and initiate and communicate corrective and preventive actions (CAPA) for resolution, working cross-functionally.
• Establish key performance indicators for the QC laboratories (e.g., OOS, Invalid Assays, OOT, Laboratory Deviations, Testing Turnaround Times, EM Data Trends, etc.).
• Implement and manage the Contamination Control Strategy (CCS) for the site, working cross-functionally.
• Absorb and assist the Quality Site Head in identifying and qualifying contracted laboratory services and/or contingent staffing as required (Disinfectant Efficacy Studies, Mycoplasma, in vitro adventitious virus testing).
• Lead QC laboratory activities required to successfully respond to regulatory requests and support regulatory and internal inspections of the facility and laboratory areas.

Skills

• Proficient in Empower, LIMS, ELN, LES, Microsoft Office Suite, Lean Lab practices, and Agile methodologies.

Benefits

The anticipated annual salary for this position is $137,300 to $185,000. The actual salary offered at the commencement of employment may vary based on several factors, including, but not limited to, relevant experience, skill set, qualifications, education (including applicable licenses and certifications), job-related knowledge, geographic location, and other business and organizational needs. The listed salary range is just one component of the overall compensation package. At Kyowa Kirin North America, we provide a comprehensive range of benefits, including:

• 401(k) with Company Match
• Annual Bonus Program (Sales Bonus for Sales Positions)
• Broad Generous PTO and Holiday Schedule, including Summer and Winter Shut-Downs
• Sick Days
• Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drug, and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long-Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Equal Employment Opportunity

Kyowa Kirin North America, Inc. is committed to providing equal employment opportunity to all qualified individuals without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affectional preference, citizenship status, or any other characteristic protected by applicable law. Applicant Privacy Notice When you apply for a position through this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller"), located at 510 Carnegie Center Drive, Princeton, NJ 08540 USA. The Controller can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. The Controller's Data Protection Officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing the Controller's recruitment-related activities, including setting up a