Advisor – Quality Audit and Compliance (Controlled Substances) at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Comprehensive knowledge of applicable regulations, particularly US DEA regulations for Controlled Substances (CS), and GxP compliance
Technical knowledge and training to meet auditing responsibilities, including interpretation of Lilly standards, regulations, regulatory guidance, and industry standards
Ability to interpret regulatory and quality standard requirements for business processes and provide guidance
Skills in building and maintaining relationships with regulatory authorities
Capability to maintain Power of Attorney documentation, manage DEA registrations, sign DEA Form 222, and complete DEA online reporting

Responsibilities

Serve as Global SSS/CS Process Owner, leading or participating in preparation and review of standards, policies, procedures, and guidelines for Quality, SSS, and CS requirements
Review proposed CS regulations (particularly US DEA), collaborate with legal and industry groups on comments, own and maintain Lilly Quality Standard 303, and handle risk assessment for SSS designation
Build and maintain relationships with regulatory authorities; facilitate and host inspections from US DEA, Indiana Board of Pharmacy, and other state CS agencies
Maintain Power of Attorney documentation to manage DEA registrations, sign DEA Form 222, and complete required online reporting via DEA website
Provide regulatory interpretation and guidance across product lifecycle for SSS and CS materials (API, drug product, finished product, samples, reference standards)
Develop or support corrective and preventive actions (CAPAs) to address gaps in SSS/CS compliance processes
Escalate compliance issues promptly and appropriately
Ensure adherence to applicable quality standards, manuals, policies, procedures, and tools
Lead or participate in planning, scheduling, preparing, conducting, escalating, and reporting audits, assessments, and due diligences of GMP Operations and SSS/CS to assess compliance

Skills

GxP Compliance

Quality Auditing

Controlled Substances

DEA Regulations

Risk Assessment

Regulatory Interpretation

Internal Audits

External Audits

Quality Assurance

Pharmaceutical Compliance

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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