Principal Associate at Eli Lilly and Company

Singapore, Singapore, Singapore

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Support the development and implementation of quality systems and activities to support business goals and objectives
Execute quality system deliverables to ensure compliance
Provide quality oversight of business areas to integrate requirements
Support audit/inspection activities and collaboration within quality and other areas
Act as a quality leader supporting functions in the Asia Pacific Region, specifically Regulatory Affairs and Patient Safety

Responsibilities

Contribute to the development of area-specific procedures, tools, resource documents, and supplemental materials, including review and content approval of quality system documents
Ensure regional and/or affiliate quality system requirements have clear accountabilities
Recommend new quality system documents or changes to existing ones
Advise on appropriate training for implementation and documentation
Provide consultation on the interpretation and practical application of external requirements, standards, and procedures
Manage deviations, change controls, and Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed
Consult on root cause analysis and corrective/preventive actions (CAPA), including review/approval
Provide input into risk assessments, audit planning, and/or quality plans based on identified signals/risks/gaps
Complete self-inspections and drive meaningful, actionable improvements
Ensure local implementation of quality systems and provide support related to external party management (e.g., third-party organizations, business alliance partners)
Monitor compliance to quality system documents, anticipate gaps, and proactively propose solutions
Communicate and escalate issues to management as appropriate
Ensure implementation of regional and/or affiliate Quality Plan(s), monitor progress, and provide updates to quality and business owners
Seek and implement simplification and process improvements
Coordinate quality improvement initiatives
Review metrics and trending to improve processes and compliance, analyze trends, identify weaknesses/gaps, and recommend corrective actions
Monitor completion of deviations, change controls, CAPA, and audit responses
Provide support for audits/inspections (e.g., preparation/readiness, coordination, back room, front room, responses)
Communicate and ensure inspection readiness (e.g., organization and availability of documents such as training records, job descriptions)
Ensure completion of audit corrective action plans and timely resolution
Lead and/or support readiness activities in collaboration with business partners
Function as the initial point of consultation for business areas on quality-related questions
Partner with business areas to strengthen and ensure appropriate quality controls are in place
Share key learnings to drive improvements

Skills

Quality Systems

Regulatory Affairs

Patient Safety

Deviations

Change Controls

Audit Support

Inspection Readiness

Compliance

Training

Procedure Development

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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