Sr Manager, Quality Assurance - Parenteral (Night Shift) at Eli Lilly and Company

Pleasant Prairie, Wisconsin, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor's degree in a science, engineering, pharmaceutical-related field of study or equivalent experience
5+ years in pharmaceutical leadership with specific QA experience, including leading or working effectively with a cross-functional group
Ability to work 8-hour days – Monday through Friday (Night Shift)
Ability to work overtime as needed

Responsibilities

Serve as technical resource to review and approve technical documents
Network with cross-functional technical project delivery team to ensure equipment and systems comply with quality requirements and are implemented with a Quality by Design framework
Work with the Associate Director, Quality Assurance to support the development of the vision, strategy and quality culture for the overall site quality assurance organization with focus on the formulation, filling and visual inspection programs
Support initial recruiting, build capability, for a diverse leadership and quality assurance staff to support qualification, validation and routine production
Manage a team of up to approximately 15 direct reports
Support the site to ensure a safe work environment including supporting and leading safety efforts for your team
Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures and controls
Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment
Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc
Network with global and other parenteral sites to understand best practices and share knowledge
Work cross-functionally with the area process teams for metrics reviews, operational support, and issue/deviation management
Support inspection readiness activities
Interact with regulatory agencies during inspections regarding cGMP issues
Ensure data integrity by design

Skills

Quality Assurance

Parenteral Manufacturing

Quality by Design

Validation

Project Management

Technical Documentation

Team Management

Safety Leadership

Process Development

Regulatory Compliance

Pharmaceutical Manufacturing

Visual Inspection

Recruiting

Cross-Functional Collaboration

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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