FREE ACCESS
5,000–10,000 jobs/day
See all jobs on JobTailor
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Quality Operations management within the pharmaceutical industry, ensuring compliance with cGMP and regulatory standards while effectively leading cross-functional teams. Proficient in overseeing quality assurance processes, managing inspections, and training personnel in Quality Control.
Highest-signal resume keywords
Quality Operations ManagementCGMP ComplianceRegulatory Knowledge (China/EU/FDA)People ManagementFluent in Chinese & English
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
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 & Qualifications
Master Degree in Scientific Field
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryCGMP RequirementsMedical Device RegulationsQuality OperationsFinished Goods ReleaseImportation ComplianceCross-Functional Team InteractionQuality Management ActivitiesRegulatory Compliance
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