Sr. Associate – GMQO Audit and Inspection Management (P1-P3-2) at Eli Lilly and Company

Cork, County Cork, Ireland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

Ability to provide support, oversight, and education to quality and business personnel on quality system components, particularly Audits, Inspections, and Notification to Management (NTM)
Capability to work closely with the GMQO process owner for monitoring and continuous improvement of Audits and Inspections processes
Proficiency in serving as SharePoint Site Administrator for MIM sites, including development and management of cross-functional inspection management infrastructure
Skills in administratively and logistically facilitating and managing backroom operations for sponsor inspections and audits hosted by Medicines Quality Organization
Competence in managing archiving of audits and inspections data and retrieving documentation from various sources

Responsibilities

Provide support, monitoring, and education to quality and business personnel for assigned quality system components, including Audits and Inspections, and Notification to Management (NTM)
Work closely with the GMQO process owner for Audits and Inspections to monitor and drive continuous improvement of the process
Serve as SharePoint Site Administrator (MIM sites) to develop and manage cross-functional inspection management infrastructure for logistics, preparation/planning, and close-out activities, including tracking sponsor requests and facilitating inspection management response processes
Administratively and logistically facilitate and manage backroom for sponsor inspections and audits hosted by Medicines Quality Organization
Manage the appropriate archiving of audits and inspections data and retrieval of documentation from various sources

Skills

Key technologies and capabilities for this role

Audit ManagementInspection ManagementQuality Assurance

Questions & Answers

Common questions about this position

What benefits does Eli Lilly Cork offer?

Eli Lilly Cork offers flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies, on-site parking, Inhouse People Development services, Educational Assistance, and ‘Live Your BEST Life’ wellbeing initiatives.

Is this a remote or hybrid role, and where is it located?

The role is based at Eli Lilly Cork's campus in Little Island and offers flexible hybrid working options.

What is the company culture like at Eli Lilly Cork?

Eli Lilly Cork features a talented diverse team of over 2000 employees across 60 nationalities, is committed to diversity, equity and inclusion (DEI) with pillars like EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network, and encourages employees to Be Creative, Be an Innovator, and Be Yourself.

What specific skills or experience are needed for the Sr. Associate role?

The role requires providing support, oversight, and education to quality and business personnel on quality system components, with primary focus on Audits and Inspections and Notification to Management (NTM), ensuring readiness for audits and inspections, and supporting continuous improvement.

What makes a strong candidate for this position?

Strong candidates should align with Lilly's mission to make life better for people, demonstrate determination, and fit into a diverse, innovative team environment focused on quality systems, audits, and inspections.

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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