Principal Associate QA

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Position

There is an opening for a Principal Associate QA IHL to support the quality systems at Eli Lilly  Cork Limited (ELC)

Background

ELC is Lilly’s wholesale entity based in Kinsale, operational since October 2025 and  is  responsible for the procurement and supply of:

1.Active substances (APIs and drug substances) sourced from both European and non-European manufacturers, including Lilly and contract manufacturers.

2.Medicinal products manufactured at European sites (both Lilly and contract manufacturers) for supply to the United State

ELC has a Quality Management System (QMS) based on European GDP requirements. ELC has a current GDP cert, an Active Substance Registration (ASR) for importing and supplying active substances and a Wholesale Distribution Authorisation (WDA) for supplying medicinal products, all are issued by the HPRA. ELC has been successfully inspected by the HPRA in 2025. ELC complies with Lilly global quality standards and is audited by GQAAC.

ELC is a new team and  consists of representatives from supply chain, finance, and quality. ELC works closely with the IHL which is another well-established wholesaler operating out of Kinsale since 2018. Working in a quality role in ELC is a unique and exciting opportunity to build new working relationship across Lilly groups such as GSC (global supply chain), MAQA (Marketing Affiliates Quality Association), Lilly and contract manufacturing sites and Lilly groups eg APIEM, Dry EM and DPEM etc.

The role involves critical thinking around new supply chains for both active substances and medicinal products imported into and exported out of Europe.  Quality responsibilities in ELC must ensure that supply chains are compliant with the Quality Management System and ELC licenses (ASR and WDA). All suppliers, customers and outsourced activities must be qualified. This involves reviewing MIAs, GMP certs, WDA etc. from many different regulatory authorities as well as ensuring audits and Quality Agreement are in place.

Strong knowledge of Good Distribution Practice (GDP) is essential; Good Manufacturing Practice (GMP) experience is advantageous. This  position requires strategic thinking and is very  rewarding.

Key Responsibilities

• Implement and maintain the Quality Management System (QMS) in compliance with EU GDP guidelines.  

• Partner with cross-functional teams, including Kinsale supply chain, tax and finance, as well as global partners such as  Lilly Affiliates, Manufacturing sites, Lilly wholesalers, API EM, Dry EM and  DPEM.

• Be prepared to be developed as a deputy Responsible Person (dRP), with potential inclusion on the ELC WDA licence if the business needs arise.

• Support both IHL and ELC HPRA inspections and GQAAC audits.

Key Objectives/Deliverables:

Quality Management System (QMS)

• Daily activities include implementation QMS which includes but is not limited to the following: Qualification of Customer & Suppliers, Outsourced activities, Self-inspection, Risk Assessment, Change Controls, Procedures, Management Review, Falsified Medicines and Returns etc.

• Prepare intracompany Quality Agreements.

• Manage audit plans and reports.

• Collect monthly metrics from key stakeholders

• Perform SAP quality activities

Compliance with Regulatory Requirement

• Ensure compliance with ELC licenses including Wholesale Distribution Authorisation (WDA) and Active Substance Registration (ASR).

• Prepare variations to the WDA and annual updates to the ASR for submission to the HPRA.

• Ensure audit preparation and readiness, support and be available to attend and support regulatory inspections (HPRA) and corporate audits (GQAAC).

• Deputise in the absence of the Responsible Person.

Document Controller

• Perform Document Controller role for Veeva Vaults Quality Docs.

Other

• Develop and maintain excellent cross-company, cross-functional and multi-geographical relationships with key internal and external stakeholders.

• Assistance on other projects as required.

• Work on IHL quality activities in conjunction with ELC activities as the need arises.

Qualifications:

• Minimum honours bachelor’s degree in a scientific or engineering discipline.

Basic Requirements:

• 3+ years of working in a GDP or GMP compliance role.

• Fluent in English language. Foreign languages may be an advantage.

• Good computer-based skills, particularly SAP or similar application and MS Office applications 

• Able to work within a team and work independently

Additional Preferences:

Experience of supporting regulatory inspections and audits is desirable.

The role will report to the  Director of QA Responsible Person IHL  

This role is a full-time position (39 hours/ week)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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