(Sr./Principal) Associate-CEM Quality at Eli Lilly and Company

Suzhou, Jiangsu, China

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

5+ years GMP experience including roles associated with production support, TS/MS and/or Quality
Bachelor or equivalent (Chemistry, Biology, Life Sciences, Pharmacy or Engineering related degree preferred)
English fluency
Strong oral and written communication and interpersonal interaction skills (preferred)
Significant leadership success in prioritization, implementation, relationship building and networking (preferred)
Background in development or implementation of quality systems (preferred)
Available to travel as needed

Responsibilities

Create quality systems to manage external manufacturing partners
Ensure GMP and appropriate Lilly GQS compliance for external manufacturing partners and the team’s own operations
Implement appropriate Lilly Quality Governance to external manufacturing partners to assure successful products launching with required quality
Participate in business planning to ensure adequate resources are available to support compliance and business needs
Engage in problem-solving and day-to-day decision-making associated with product batch release, validation, and deviations, as needed
Incorporate Quality by Design concepts where appropriate and strive to continuously reduce deviation, complaints and open quality actions
Create a strong collaborative working relationship with the external manufacturing partners’ Quality leaders and jointly develop a detailed understanding of decision-making rights
Partner with CEM leader to create a strong cohesive team to manage the external manufacturing partners
Work with global Lilly manufacturing and quality staff to learn best practices that exist elsewhere
Follow various HSE management procedures and fulfill the work safety responsibilities
Provide quality oversight and support for manufacturing activities associated with external partnerships, including batch disposition and product testing, validation, Change Management, Deviation Management, Periodic reviews, Auditing, Complaints Management and Document Control

Skills

Key technologies and capabilities for this role

GMPQuality ManagementValidationChange ManagementDeviation ManagementAuditingBatch DispositionProduct TestingComplaints ManagementDocument ControlPeriodic ReviewsQuality by Design

Questions & Answers

Common questions about this position

What are the basic qualifications for this role?

Candidates need a Bachelor’s degree or equivalent, preferably in Chemistry, Biology, Life Sciences, Pharmacy, or Engineering, along with 5+ years of GMP experience in roles related to production support, technical services, manufacturing science, or Quality.

What is the salary range for this position?

This information is not specified in the job description.

Is this a remote position or does it require office presence?

This information is not specified in the job description.

What does the company culture emphasize at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people, puts people first, and seeks determined individuals who give their best effort while focusing on global healthcare impact through philanthropy and volunteerism.

What experience makes a strong candidate for this role?

Strong candidates will have 5+ years of GMP experience in production support, technical services, or quality management, plus a relevant degree, and the ability to build quality systems, ensure compliance, and foster collaborative relationships with external partners.

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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