CMC Regulatory Quality Advisor at Eli Lilly and Company

Indianapolis, 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, HealthcareIndustries

Requirements

Familiar with regulations and guidelines, able to provide interpretation and define quality direction to comply with external and internal expectations
Expertise in corrective and preventative actions (CAPA) management, deviation/change management, root cause investigation
Experience in performing on-going risk assessments, quality system evaluations, and recommending corrective actions
Skilled in proactive data analysis to identify emerging issues, trends, and opportunities
Knowledge of Global Quality Auditing and Compliance (GQAAC) processes and audit planning
Ability to define, execute, and document quality self-assessments and self-inspections
Experience serving as Business Quality Assurance (BQA) for critical business systems, including IT systems per Computer System Policies and Procedures
Capable of quality consultation for Safety and Efficacy Quality System (SEQS) components, interacting with cross-functional groups (e.g., Legal, Compliance, Finance, CDDA)
Leadership skills to manage two direct reports and foster a collaborative team environment
Participation in strategic planning for SEQS effectiveness and quality integration into business processes

Responsibilities

Provide direct quality support to Global Regulatory Affairs (GRA), focusing on Chemistry, Manufacturing, and Controls (CMC) business function, ensuring compliance and driving quality excellence
Provide key input into the design of the Quality System and lead its implementation into the business area, accountable for milestones
Provide guidance and expectations for execution of regulations at local, regional, and global levels, ensuring compliance and inspection readiness
Develop and implement quality strategy for portfolio and functions, partnering on quality risk assessments and risk management plans
Perform on-going risk assessment and evaluation of the quality system to identify gaps and recommend corrective actions
Engage in proactive data analysis for assigned area to identify issues, trends, and opportunities for continuous improvement
Ensure deviation/change management, root cause investigations, and CAPAs are managed, documented, escalated, and completed
Report issues through Notification to Management (NTM) as appropriate
Provide input into GQAAC audit plans based on identified risks/gaps
Define, execute, and document quality self-assessments/self-inspections and discuss with business partners
Serve as BQA for critical business systems, including reviewing/approving IT system documents and partnering on system initiatives/changes
Provide quality consultation for assigned SEQS component, interacting across organizations
Lead inspection readiness and inspection management

Skills

CMC Regulations

Regulatory Affairs

Quality Systems

GMP

Regulatory Compliance

SEQS

Quality Assurance

Strategic Planning

Regulatory Guidelines

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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