Sr. Manager, Quality Control - Kyowa Kirin North America : Job Details

Sr. Manager, Quality Control

Kyowa Kirin North America

Job Location : Sanford,NC, USA

Posted on : 2024-12-01T06:37:52Z

Job Description :

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.Summary:The Sr. Manager, Quality Control will play a critical role designing and executing the operational readiness program for start-up of the Quality Control laboratories at the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford, NC. The Sr. Manager position will lead and enable the timely completion of key milestones for ensuring production targets are achieved. This role will initially be involved working in a greenfield environment and will transition to lead the Lab operations throughout the GMP-ready, Tech Transfer, and facility licensure activities for the manufacturing of Phase III and early commercial products. Accountable to ensure compliance of the QC laboratory areas with current GxP Standards and with all applicable Global, Regional, and Site procedures within Kyowa Kirin's Quality Management System.Essential Functions:•Provide technical leadership collaborating cross-functionally in the site early-stage activities, including: facility detail design review; facility, equipment and analytical instruments user requirements review; prioritization for implementation of equipment, instruments and analytical methods required for facility start-up (GMP ready/OQ Complete); ICT efforts for developing user requirements and procuring selected electronic Quality Systems for the 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 a robust and compliant and timely implementation for all the 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.). •Coordinate testing and reporting of laboratory results in support of the facility Environmental and Utility monitoring program.•Lead the QC Lab 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 staffing per approved staffing plans.•Lead/ensure timely investigation of deviations, laboratory exceptions, or other cGMP issues at the site and initiate and communicate actions (CAPA) for resolution working cross-functionally. •Establish key performance indicators for the QC laboratories (for example: OOS, Invalid Assays, OOT, Lab Deviations, Testing Turn-around-Times, EM Data trends, etc.).•Implement and manage the Contamination Control Strategy (CCS), for the site, working cross-functionally.•Assist Quality Site Head in identifying and qualifying contracted lab services and/contingent staffing as required (Disinfectant Efficacy Studies, Mycoplasma, in vitro adventitious virus testing).•the QC Lab activities required to successfully respond to regulatory requests, complete regulatory and internal inspections of the facility and laboratory areas.Requirements:EducationBachelor's degree in life sciences (minimum)Master's degree in life science (preferred)ExperienceAt least 7 years of management experience leading GMP Bio-Pharmaceutical Quality Control laboratories and support areas, such as: QC Sample Management, Microbiology, Raw Materials, Chemistry/Biochemistry, Stability, Bioassay, and/or Virology. Experience leading and conducting investigation of non-conformances, in-depth understanding of the quality control procedures and relevant regulatory standards, as well as experience managing and/or participating in regulatory agency inspections of laboratory control areas.Experience with starting up and managing a new facility is a plus. This includes facility design reviews, facility and equipment user requirements review, defining computerized systems requirements for the laboratories (LIMS/ELN, Empower), experience supporting facility, utilities, and equipment qualification efforts. Technical SkillsProficient in MS Office Suite, Lean Labs, or Agile lean.KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactionsIt is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ( Controller ), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing [email protected]. Controller's data protection officer can be contacted at [email protected]. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 ( GDPR ) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at [email protected] & Staffing AgenciesKyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.#LI-TT1 #Sanford #On-Site

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