Principal Associate Global Medicines Quality Organization-China at Eli Lilly and Company

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Expertise in GxP areas (e.g., Good Clinical Practice, Good Pharmacovigilance Practice)
Ability to monitor external regulatory landscape and conduct gap analysis
Technical expertise to shape external environment and strengthen Lilly Quality Management System
Knowledge of international and local laws/regulations
Skills in root cause analysis, CAPA design, and implementation
Experience with risk assessment and quality planning
Understanding of Safety and Efficacy Quality System (SEQS)
Proficiency in reviewing and developing procedures, tools, forms, and templates
Capability to perform self-inspection, quality oversight visits, and risk mitigation
Knowledge of inspection management and regulatory interpretation as Subject-Matter-Expert
Ability to analyze trends, metrics, and drive corrective actions
Skills in coordinating quality improvement initiatives and training

Responsibilities

Implement and manage Quality Systems
Monitor external regulatory landscape and lead internal gap analysis in GxP areas
Contribute to external environment shaping by providing technical expertise in GxP areas
Communicate regulatory changes to global and local quality/business partners
Coordinate or lead Quality Management System improvements with global and affiliate areas
Provide consultation on integrating quality into business processes
Guide business on quality management system applications (e.g., deviation, change control, notification)
Coordinate or conduct root cause analysis and guide CAPA implementation
Manage or contribute to affiliate risk assessment and quality plan
Ensure local implementation of Safety and Efficacy Quality System (SEQS)
Review global policies, standards, procedures, and local procedures for implementation
Recommend new or changed procedures where applicable
Provide quality oversight for SEQS and local quality system compliance
Escalate compliance issues to local and global management
Plan and conduct risk-based quality oversight activities (e.g., self-inspection, site visits)
Act as quality consultant for risk identification, assessment, and mitigation
Provide support for outsourced activities aligned with internal standards
Manage and support audit and inspection activities (e.g., readiness, training, leading audits/inspections)
Coordinate audit and regulatory responses, including documentation
Drive trending of metrics to improve processes and compliance (e.g., deviations, CAPA, audits)
Analyze trends, identify weaknesses/gaps, and recommend corrective actions
Monitor completion of implementation actions from deviations, CAPA, changes, audits, and self-inspections
Provide periodical inspection/quality metrics and recommendations to management
Share key learnings to drive quality-by-design and process improvement locally and globally
Organize and support quality-related training
Lead or facilitate quality topics at affiliate communication platforms to foster quality culture
Understand handling of confidential information (e.g., patient privacy)

Skills

Key technologies and capabilities for this role

Quality SystemsGxPGood Clinical PracticeGood Pharmacovigilance PracticeGap AnalysisRegulatory ComplianceQuality Management SystemDeviation ManagementChange ControlRoot Cause AnalysisCAPARisk AssessmentSEQS

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require working in an office?

This information is not specified in the job description.

What key skills or experiences are required for this role?

The role requires expertise in GxP areas like Good Clinical Practice and Good Pharmacovigilance Practice, experience with Quality Management Systems including deviation, change control, and CAPA, and skills in regulatory interpretation, audit management, and risk assessment.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people around the world, puts people first, and values giving best effort to work while contributing to communities through philanthropy and volunteerism.

What makes a strong candidate for this Principal Associate role?

Strong candidates will have deep expertise in GxP compliance, experience leading quality system improvements, audit and inspection management, and the ability to provide technical consultation on regulatory matters and risk mitigation.

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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