External Senior Quality Manager-API

Outstanding global MNC

Your new company
In this position you will lead quality oversight for external manufacturers in the China region, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards.

Your new role
Provide quality leadership and technical support to ensure effective and compliant execution of quality systems at external manufacturing sites Manage quality oversight in the selection, qualification, and ongoing monitoring of external partners Lead the identification and resolution of quality issues and complaints, including facilitation of investigation process and development of robust CAPA plans. Review and approve quality systems documentation, including product disposition, manufacturing instructions, change controls, specifications, validation documentation, and technical studies Monitor quality performance through the development of key performance indicators; Analyze data to identify risks and drive implementation of mitigation plans Build relationships with internal and external partners; Influence external manufacturers to continuously improve processes and procedures focused on reliability, execution, and quality culture Collaborate with External Manufacturers to support health authority inspections; monitor and follow-up on associated response and commitments Provide oversight for tech transfer and new product introduction activities; lead API readiness activities, and support associated health authority filings and approvals Partner with External Manufacturing sites to define the quality strategy through benchmarking and knowledge sharing. Lead risk management initiatives necessary to improve performance Partner with key internal stakeholders in support of supply chain to meet patient supply requirements

What you'll need to succeed

What you'll get in return

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1228884


Job Type
Life Sciences

Talk to a consultant

Talk to Gioia Wang, the specialist consultant managing this position, located in Shanghai
Unit 1205-1212, HKRI Centre One, HKRI Taikoo Hui, 288 Shimen Road (No.1)

Telephone: 02123229656

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