Sr. Manager, Quality Assurance- GMP Biopharmaceuticals
1 month ago
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 Assurance will play a critical role in the design, start-up, and oversight of the Quality Assurance organization within the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford, NC. This role will initially involve working in a greenfield environment and will transition to lead the Quality Assurance organization 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 Quality Unit and Manufacturing operations with current GxP Standards and with all applicable Global, Regional and Site procedures within Kyowa Kirin's Quality Management System.
Essential Functions:
• Provide quality and compliance 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).
• Leverage global electronic QMS Structure in VEEVA to establish and maintain Site Quality Assurance procedures as applicable to stand the Site QMS and develop GxP training requirements for QA Staff.
• Establish a Site Risk Management procedure seeking to ensure a consistently robust and compliant methodology is implemented for the documentation of risk-based approaches and decisions based on sound rationales, with justifications supported by facts and data.
• Lead and coordinate cross-functionally the robust and compliant and timely implementation of the required Site procedures in support of the QMS and Contamination Control Strategy.
• Establish procedures for batch record review, product quarantine, and disposition in compliance with all applicable regulatory requirements (JP, USP, EP, etc.).
• Lead all GXP operations to ensure production targets are achieved compliantly within the Manufacturing, Warehouse, Engineering, and Laboratory areas.
• Review and approve 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 compliance with current regulatory requirements for Data Integrity (ALCOA+) requirements as applicable to paper and electronic records (21 CFR Part 11).
• Hire, onboard, train, and mentor QA employees and/or contractors per approved staffing plans.
• Lead/ensure timely investigation of non-conformances, deviations, laboratory exceptions, or other cGMP issues at the site and initiate and communicate actions (CAPA) for diligent and effective resolution.
• Establish key performance indicators for Site Quality Metrics including Deviations, CAPAs, Change Controls, OOS, Invalid Assays, OOT, Equipment Failures, EM Data trends, Stability Trends, Product Disposition Cycle-times, etc.).
• Provide leadership to establish a robust culture of quality based on patient-focus, sustainable compliance, and inspection-readiness for all GxP areas within the facility and laboratory areas.
• Assist the Site Quality Head in developing, approving, and communicating the quality goals and objectives for the site. Ensure progress against goals is monitored and reviewed with Site Leadership Team, and key stakeholders.
Requirements:
Education
Bachelor's degree in life sciences (minimum)
Master's degree in life science (preferred)
Experience
At least 7 years of management experience leading GMP Bio-Pharmaceutical Quality Assurance teams, such as: QA Document Control, QA Training, QA Inspections, QA Batch Disposition, QA Shop Floor Teams, Lab QA, Quality Agreements Team, QA Vendor Qualification Team, Incoming Quality Assurance, Logistics QA, etc.
Experience leading and conducting investigation of non-conformances, in-depth understanding of the QMS procedures and relevant regulatory standards, as well as experience hosting, leading, and/or coordinating regulatory agency inspections of Bio-Pharmaceutical Manufacturing facilities and supporting 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 Manufacturing (MES/ERP/eBR/LIMS), Engineering (CMMS, eVAL, BMS), and laboratories (LIMS/ELN, Empower).
Experience reviewing and approving Engineering Plans and GxP documentation in support of the equipment, facilities, and processes qualification efforts (Validation protocols, reports, test plans, Project Verification Plans, Validation Master Plans, Site Master File, etc.).
Technical Skills
Proficient 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 interactions
It 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 Controller's data protection officer can be contacted at 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
Recruitment & Staffing Agencies
Kyowa 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 #NC #North Carolina
-
Manufacturing Quality Assurance Specialist
2 days ago
Sanford, North Carolina, United States Eurofins USA PSS Insourcing Solutions Full timeJob Summary:The Manufacturing Quality Assurance Associate contributes to Quality Assurance on the floor activities related to drug substance manufacturing at Eurofins USA PSS Insourcing Solutions. This role is responsible for providing quality oversight of manufacturing documentation, housekeeping, and overall GMP compliance.Key Responsibilities:Performs...
-
Quality Assurance Associate
2 days ago
Sanford, North Carolina, United States Eurofins USA PSS Insourcing Solutions Full timeJob Summary:The Manufacturing Quality Assurance Associate contributes to Quality Assurance on the floor activities related to drug substance manufacturing at Eurofins USA PSS Insourcing Solutions. This role is responsible for providing quality oversight of manufacturing documentation, housekeeping, and overall GMP compliance.Key Responsibilities:Performs...
-
Supplier Quality Assurance
22 hours ago
Sanford, United States Integrated Resources, Inc ( IRI ) Full timePosition: Supplier Quality Assurance SpecialistLocation: Sanford - Oak Park, NCDuration: 18 monthsSchedule: M-F 1st ShiftJob Description:Supports the Client Sanford, NC, Quality Operations department by performing Quality Assurance activities including suppler qualification and management, and enrollment of new materials and suppliers associated with...
-
Sr. Manager, Quality Control
1 month ago
Sanford, United States Kyowa Kirin Full timeKyowa 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...
-
Quality Assurance Specialist
22 hours ago
Sanford, United States Randstad Life Sciences US Full timeQuality Assurance Specialist- First ShiftActual Job Title: Supplier Quality Assurance Specialist18 MonthsSanford, NCJob DescriptionSupports the Sanford, NC, Quality Operations department by performing Quality Assurance activities including suppler qualification and management, and enrollment of new materials and suppliers associated with clinical and/or...
-
Quality Assurance Specialist
22 hours ago
Sanford, United States Net2Source Inc. Full timeJob Title: Quality Assurance SpecialistLocation: Sanford, NCDuration: 18+ Month ContractJob Responsibilities: Supports the Client's Sanford, NC, Quality Operations department by performing Quality Assurance activities including suppler qualification and management, and enrollment of new materials and suppliers associated with clinical and/or commercial...
-
Quality Assurance Manufacturing Specialist
1 week ago
Sanford, North Carolina, United States Actalent Full timeJob Title: Quality Assurance Manufacturing SpecialistJob Overview: A leading global pharmaceutical manufacturer is in search of a Quality Assurance Manufacturing Specialist to assess and scrutinize production processes. This role encompasses the evaluation of incoming material approvals, batch release assessments, investigations, change management, and other...
-
Sanford, North Carolina, United States Eurofins USA PSS Insourcing Solutions Full timePOSITION SUMMARY:The Quality Assurance Specialist in Manufacturing plays a vital role in ensuring quality standards during the production of drug substances. This position requires a solid understanding of Good Manufacturing Practices (GMP) and adherence to established protocols to oversee manufacturing documentation, cleanliness, and overall compliance with...
-
Quality Control Specialist in Manufacturing
1 week ago
Sanford, North Carolina, United States Actalent Full timePosition Overview:Our client, a leading global pharmaceutical manufacturer, is in search of a Quality Control Specialist to assess and oversee manufacturing processes. This role involves evaluating various activities including the release of incoming materials, batch releases, conducting investigations, managing change controls, and other essential tasks to...
-
Quality Assurance Specialist
4 days ago
Sanford, Florida, United States Aero Support Group Full timeQuality Assurance Specialist at Aero Support GroupAre you an experienced Quality Assurance Specialist looking for a new opportunity? Aero Support Group is currently seeking a qualified candidate to join our team.**Job Summary:**We are seeking a Quality Assurance Specialist responsible for inspecting airframe, engines, and operating equipment to ensure...
-
Pipeline Quality Assurance Specialist
2 weeks ago
Sanford, United States PURIS Corporation, LLC Full timeJob DescriptionJob DescriptionPipeline Quality Assurance SpecialistAbout PURIS:PURIS operates across North America as the largest independent trenchless rehabilitation provider with 900+ employees dedicated to building lasting infrastructure with smart, sustainable resource management. The PURIS Family of Companies provides trenchless renewal solutions in...
-
QC Analytical Scientist
3 weeks ago
Sanford, United States Eurofins Full timeCompany DescriptionThe work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and...
-
Quality Assurance Specialist
1 week ago
Sanford, North Carolina, United States BIS Full timePosition OverviewWe are seeking a dedicated Quality Inspector to enhance our operations at Broadwind Industrial Solutions. This role is pivotal in ensuring that both incoming and outgoing materials and products adhere to stringent quality standards.Key Responsibilities1. Monitor and audit quality requirements in alignment with company policies and customer...
-
Quality Assurance Specialist
5 days ago
Sanford, North Carolina, United States BIS Full timePosition OverviewWe are seeking a dedicated Quality Inspector to join our team at Broadwind Industrial Solutions. This role is crucial in maintaining the high standards of our products and processes.Key Responsibilities1. Ensure compliance with quality assurance policies and customer specifications through regular audits and monitoring.2. Conduct thorough...
-
Quality Assurance Specialist
7 days ago
Sanford, United States Pioneer Data Systems Inc Full timeOur client, a world-leading Pharmaceutical Company in Sanford, NC is currently looking for a Quality Assurance Specialist to join their expanding team. Position Details: Job Title: Quality Assurance Specialist / Pharma Industry Duration: 18 months contract, extendable up to 36 months Location: Sanford, NC Note: The client has the right-to-hire you...
-
Manufacturing QA Associate Second Shift
3 months ago
Sanford, United States Eurofins USA PSS Insourcing Solutions Full timeJob Description _ POSITION SUMMARY:_ The Manufacturing QA Associate contributes to Quality Assurance on the floor activities related to drug substance manufacturing. The colleague uses fundamental knowledge of GMP, and established procedures methodologies to provide quality oversight of manufacturing documentation, housekeeping, and overall GMP compliance....
-
Senior Construction Project Supervisor
1 week ago
Sanford, United States SR Construction Services Full timeExciting Opportunity: Senior Construction Project Supervisor at SR Construction ServicesThe Senior Construction Project Supervisor is responsible for managing daily operations on projects that involve renovations or new builds. Reporting directly to the Project Manager, this role is essential in fostering safe, efficient, and professional interactions among...
-
Quality Assurance Specialist
3 days ago
Sanford, United States Pioneer Data Systems Inc Full timeOur client, a world-leading Pharmaceutical Company in Sanford, NC is currently looking for a Quality Assurance Specialist to join their expanding team. Position Details: Job Title: Quality Assurance Specialist / Pharma Industry Duration: 18 months contract, extendable up to 36 months Location: Sanford, NC Note: The client has the right-to-hire...
-
Manufacturing QA Associate
2 months ago
Sanford, United States Eurofins Full timeCompany DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with...
-
Aircraft Quality Assurance Specialist
3 days ago
Sanford, Florida, United States Aero Support Group Full timeAircraft Quality Assurance Specialist at Aero Support GroupAre you a skilled Aircraft Quality Assurance Specialist seeking a new challenge? Aero Support Group is on the lookout for talented individuals to join our dynamic team. We offer a comprehensive benefits package including Paid Time Off, Paid Holidays, 401K, and Medical/Dental/Vision/Supplemental...