QA Compliance Manager
BeiGene
Suzhou Manufacturing
17小时前

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Job Description : Support the project management (audit planning, audit report distribution, audit response management, and audit follow up) of all compliance audits conducted in the APAC Lead and organize quality improvement plan to ensure that quality initiatives are executed and maintained in compliance with cGMP requirements Support Global Quality Systems and implementation of Global Standards in China Provide Quality guidance and support for investigations and change controls Coordinate and conduct qualification review and periodic re-assessment of suppliers in the APAC Work with Global Supplier Management to ensure accuracy of supplier data across BeiGene network sites Support health authority inspections and partner audits Assess and revise, as needed, SOPs for GMP Quality functions and identify opportunities to streamline systems and processes Lead and support the assessing quality gaps between the local BeiGene site SOPs and the Global Standards.

Take the responsibility in bridging and implementing solutions to these identified gaps. Work with and support the Global Compliance Team on the development of a compliance scorecard.

Perform duties as assigned to ensure compliance to global and local regulations Qualification Required : Core Competencies, Knowledge and Skill Requirements Solid knowledge of GMPs (EU, US, CN, AU, JP) Expert in quality system implementation and improvement Demonstrated experience in project management Excellent verbal, written and interpersonal communication skills Ability to work independently with scientific / technical personnel Ability to work in a global setting Communication & Interpersonal Skills Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail Significant Contacts Interacts with all levels of BeiGene employees including CMOs and suppliers Follow Us on MoSeeker!

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