Senior Manager, Quality Control External Commercial Biologics
Vor 7 Tagen
We are seeking a highly experienced Senior Manager, Quality Control External Commercial Biologics to join our team at Incyte. This is a critical role that will be responsible for ensuring the quality of our commercial biologics products manufactured externally.
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.
- Ensure that QC framework processes and policies/standards are established, implemented, audited, and continuously improved to ensure compliance with regulatory standards and company policies.
- Review project plans, quality agreements, contracts, manufacturing documents, CMOs, and Incyte CPV and APQR reports associated with external commercial manufacturing.
- Provide technical support for CMO 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, and 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.
- Support the 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.
- 5 years of relevant experience with a Master's degree or 10 years of experience with a Bachelor's degree.
- Knowledge in protein chemistry and large molecules is a must.
- Extensive experience with analytical instrumentation and analytical drug product lifecycle.
- Statistical analysis skill.
- Operational Excellence/LEAN is a nice to have.
- Strong written and verbal communication and organization skills are required.
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