External Quality Lead – Authorized Qualified Person

Biogen

Quality Lead overseeing Biogen's operations for commercial products in China. Ensuring compliance with regulations and managing quality operations in a cross-functional team setting.

Posted 7/1/2026full-timeShanghai • 🇨🇳 ChinaSeniorWebsite

About the role

Key responsibilities & impact

Oversee strategy and execution of Quality operations for Biogen commercial products in China
Act as Authorized Qualified Person for finished goods release and importation
Ensure compliance with laws and regulations
Manage China Site Quality team and RP release delegates
Communicate quality issues to senior management and influence resolution
Interact with cross-functional teams such as Planning, Logistics, Sourcing, etc.
Manage Health Authority inspections and quality management activities
Identify compliance gaps and collaborate to resolve issues
Approve specifications, testing methods, and quality management procedures
Ensure timely training of personnel in Quality Control and Quality Assurance

Requirements

What you’ll need

Master degree in scientific field (Pharmacy, Chemistry, Biology, Biochemistry, etc)
A minimum of 10 years of experience in pharmaceutical or biotechnology industries (small molecules and/or biotechnology and/or aseptic filling)
At least three years of practical experience in sterile drug production and quality management
Sound knowledge of cGMP requirements
China/EU/FDA regulations and compliance
Experience in clinical products manufacturing and/or regulatory is an asset
Knowledge of medical device regulations and manufacturing is a plus
Experience in people management
Strong communication skills
Ability to work in an international matrix environment
Strong Negotiation skills
Fluent in Chinese & English

Benefits

Comp & perks

Competitive salary
Flexible working hours
Professional development budget
Home office setup allowance
Global team events

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Management ProceduresSterile Drug ProductionQuality AssuranceQuality ControlSpecifications ApprovalTesting MethodsCompliance Gap IdentificationHealth Authority InspectionsClinical Products ManufacturingAseptic Filling

Soft Skills

Strong Communication SkillsStrong Negotiation SkillsAbility to Work in an International Matrix Environment

Certifications

Master Degree in Scientific Field