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Manager of Quality Control for External Biologics
vor 2 Monaten
This role is responsible for analytical support to commercial manufacturing performed externally at contract manufacturing organizations (CMOs). The position will work closely with the Director, External QC Commercial Biologics, and will be actively engaged with collaborators/partners, CMOs, and internal groups to support product specifications, stability, investigations, analytical method transfer, validation, and annual product review. The ideal candidate will have solid scientific knowledge of various analytical methods, broad and relevant industrial experience, familiarity with ICH and other international guidance, as well as global regulatory requirements to support global filing strategy.
Key Responsibilities:
• Manage and support the timely and effective completion of events, deviations, investigations, change controls, and CAPAs, incorporating risk management principles into the management and decision-making process while promoting quality awareness and continuous improvement.
• Ensure QC framework processes and policies/standards are established, implemented, audited, and continuously improved to ensure compliance with regulatory standards, company policies, and standard operating procedures.
• Review project plans, quality agreements, contracts, manufacturing documents, CMOs, and Incyte CPV and APQR reports associated with external commercial manufacturing.
• Provide technical support for CMOs and QC lab in Agency Inspectors' routine inspections。
• Ensure data quality produced by CMOs is maintained by performing data reviews per SOP requirements.
• Work with CMOs to complete lot disposition, identify and resolve testing issues, and provide analytical expertise and support for product investigations, improvements, etc., to ensure continued compliance with regulations.
• Provide analytical SME support in analytical technical transfer and reagent supply needs for REALM/ROW activities.
• Coordinate, set up testing plans, and manage client testing for specific ad hoc testing required for stability and release.
• Monitor and manage stability testing programs to ensure compliance and reliability.
• Give support for ensuring successful tech transfer of validated methods from one partner/CMO to another as projects may require.
• Revise and approve analytical test methods that progress from development to the commercial arena.
• Provide data and input for CMC dossier preparation, submission efforts, and agency response to questions.
• Transfer and organize stability and release data, COAs, COTs, reports, investigations into Incyte quality management systems (LIMs, Veeva), and manage business share points with external/internal entities.
• Report out specified key performance indicators and communications, specific to quality and associated processes, and understand and propose improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies.
• Identify opportunities for continuous improvement of analytical methods or techniques and justify implementation plans to development teams.
• Effectively interact with other departments, quality groups (internal and external), bulk and finished product manufacturing, materials, supply chain, regularity affairs, finance, contracts, and HR.
• Support the budget follow-up (PO request, Invoicing, and Costs tracking).
