Senior Director Quality Control at Eli Lilly and Company

Lebanon, Indiana, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, ManufacturingIndustries

Requirements

Knowledge of cGMPs, applicable global regulatory manufacturing guidance, and corporate/industry standards for validation
Experience balancing coaching of technical staff, prioritization, staffing for routine production support, technical projects, and process optimizations
Ability to provide administrative and technical leadership in development, performance, and maintenance of QC Labs during start-up, implementation, and operations
Flexibility to support project delivery, build new organization, develop/implement systems and business processes for GMP operations, and build site culture
Significant collaboration, creativity, and resilience skills

Responsibilities

Provide technical leadership, performance management, training, and development of staff
Maintain a safe work environment
Ensure GMP compliance
Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc
Partner within Quality Control and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives
Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits
Ensure adequate oversight and technical excellence for investigations and complaints
Collaborate with site team to develop the strategy for the technical agenda to improve process control, yield, efficiency, and productivity for all products within the site portfolio
Provide oversight for technical projects to improve process control, capacity, yield, and quality
Ensure adequate technical representation and engagement within the site and network governance meetings to influence technical agendas
Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites
Engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes

Skills

Key technologies and capabilities for this role

cGMPGMPValidationAPI ManufacturingQuality ControlLaboratory ManagementProcess OptimizationRegulatory ComplianceTechnical Leadership

Questions & Answers

Common questions about this position

What is the location for this Senior Director Quality Control role?

The role is based at the Lilly Lebanon API site (LP1), a new advanced manufacturing facility located in Lebanon, IN.

What salary or compensation is offered for this position?

This information is not specified in the job description.

What key skills and experience are required for the Senior Director Quality Control role?

The role requires knowledge of cGMPs, global regulatory manufacturing guidance, corporate/industry standards for validation, technical leadership, performance management, and ensuring GMP compliance.

What is the company culture like at Eli Lilly for this role?

Eli Lilly emphasizes uniting caring with discovery, putting people first, giving best effort to work, and building site culture through collaboration, creativity, and resilience during the startup of the greenfield manufacturing site.

What makes a strong candidate for this Senior Director Quality Control position?

Strong candidates will have experience providing technical leadership in QC labs, balancing staff coaching with project delivery in a startup GMP environment, and cross-functional collaboration to ensure compliance and successful operations.

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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