(Senior) Associate - Product Quality - NL at Eli Lilly and Company

Utrecht, Utrecht, Netherlands

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Knowledge of Global Quality Standard GQS 181 Marketing Affiliate Operations and Common Quality Practice CQP 181-1 Product Quality Operational Manual
Understanding of local regulatory requirements in The Netherlands for product quality, medical devices, controlled drugs, and Lilly-designated Special Security Substances
Ability to support and backup the Product/MAH Quality Representative (PQR) role
Capability to implement and maintain an affiliate product quality system, including manuals, SOPs, deviation management, CAPAs, change control, notifications, monitoring, trending, quality plans, self-inspections, and complaint systems
Experience managing external parties, service providers, suppliers, and customers for quality compliance
Skills in handling product returns, rejections, recalls, falsified products, physician-sampling programs, serialization alerts, suspect/tampered/counterfeited products, and promotional items impacting quality or safety
Ability to ensure suitable areas and processes for product customization (e.g., stickers, stamping, special packaging)
Competence in communicating with Regulatory Authorities on product quality matters, MAH responsibilities, shortages, counterfeits, and defects

Responsibilities

Support the Marketing Affiliates organization on product quality related to Dutch Legal entities (Lilly Netherlands and ELEXSA NL) and provide quality oversight for Eli Lilly products and medical devices distributed in The Netherlands via the affiliate quality system
Support product quality related matters and report on quality issues within the affiliate in conjunction with the Product/MAH Quality Representative (PQR), Regional Quality Leader (RQL), and Responsible Person (RP) as needed
Promptly escalate and consult on issues to PQR, RQL, and/or management for resolution
Support implementation of a Product Quality Management System, including Local Product Quality Manual, SOPs, deviation system (investigation, documentation, CAPAs), change control, notification to management, monitoring/trending, affiliate quality plan, self-inspection/inspection, and product complaint system
Keep appropriate records of delegated duties
Support external party management, including service providers handling/distributing products, ensuring quality expectations per local/Lilly requirements and controlled drugs/Special Security Substances
Support approval of suppliers and customers
Support final disposition of returned, rejected, recalled, or falsified products in conjunction with RP per CQP 181-1
Support management of physician-sampling programs per product quality and applicable requirements
Ensure process for managing serialization alerts, reports of suspect/tampered/counterfeited products from complaints, adverse events, or returns per local regulations/Lilly standards
Support Product Complaint Process per local legislation and local/global procedures
Ensure acceptability of promotional items potentially impacting product quality or patient safety
Work with regional quality leader and Responsible Person to assure suitable areas/processes for additional operations on finished products prior to distribution (e.g., stickers, stamping, special packaging)
Ensure appropriate communication with Regulatory Authorities on product quality matters and MAH responsibilities, including shortages, counterfeits, and quality defects, in conjunction with PQR and Responsible Persons

Skills

Key technologies and capabilities for this role

Product Quality ManagementDeviation ManagementCAPASOPRegulatory ComplianceQuality AssuranceGMPMedical DevicesQuality System

Questions & Answers

Common questions about this position

What is the employment type for this Product Quality Associate role?

The position is full-time employment.

Is this Product Quality Associate position remote or office-based?

This information is not specified in the job description.

What are the key responsibilities for the Product Quality Associate?

Key responsibilities include supporting product quality matters, implementing and maintaining the affiliate product quality system per GQS 181 and local regulations, managing deviations, change control, complaints, and external party oversight, and serving as backup to the Product/MAH Quality Representative.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people around the world, puts people first, gives best effort to work, and engages in philanthropy and volunteerism while seeking determined individuals.

What makes a strong candidate for the Product Quality Associate role?

Strong candidates should have experience supporting product quality systems, knowledge of regulatory requirements like GQS 181 and CQP 181-1, and ability to manage deviations, CAPAs, change control, complaints, and external parties in a pharmaceutical affiliate setting.

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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