QA Manager

Job Description :

General Description :

The incumbent is responsible for set up and maintenance of phase-appropriate quality management systems to support BeiGene CGT product development and ensuring adherence to global regulatory requirements.

Essential Functions of the job :

• Harmonize with BeiGene Global Quality Standard and changing regulations to achieve continual improvement to support BeiGene TW Cell Therapy.
• Continually set up and maintain the phase-appropriate quality management system for TaiWan Cell Therapy in compliance with BeiGene Global Quality Standard and US cGMP, PIC / S GMP and cGTP to support product development.
• Manage governance and procedure document in QMSs and responsible the workflow of controlled document implementation.
• In collaboration with External supply quality team for vendor management.
• Responsible for controlled document archiving, issuing and maintenance such as controlled document / batch record issuing, label issuing, GXP document / record archiving, etc.
• Responsible for raw material qualification and release process such as checking record review, COA review, testing result review, and label issuing.
• Handle quality events such as change control, deviation, CAPA, risk assessment, compliant and recall are executed in time and compliant with SOP and regulatory requirement.
• Manage and review on facility, equipment, instrument qualification and commission.
• Review batch record, test reports, EM record, ongoing stability data and so on to release / reject cell bank / final product.
• Review the protocol and report of analytic method verification / validation.
• Review the protocol and report of aseptic process / process validation
• Monitor and negotiate with contract facility to ensure GMP compliance of their service.
• Support quality internal audit to comply with BeiGene quality standard and ensure the GMP / GTP / GDP requirements are met during HA inspection.
• Support and coordinate with Global Compliance for third Party WH and distributor qualification (typically for Cold-Chain products), ensure compliance of GDP activities.
• Conduct GMP, GTP related training, to ensure operations of business functions are fully compliant with quality standard and regulations.
• Review the quality event trend and KPIs, support the senior leadership to proceed quality oversight through Quality Management Review.
• Participate in department budget’s estimate and planning.

Qualification Required :

Core Competencies, Knowledge and Skill Requirements

Communication & Interpersonal Skills

Experience

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