Senior Associate - Product Quality - NL

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

As the Product Quality Associate for The Netherlands:

• Support the Marketing Affiliates organization about the 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 through the affiliate quality system via:
• Implementation and maintenance of an affiliate product quality system as required by Global Quality Standard GQS 181 Marketing Affiliate Operations and the Common Quality Practice CQP 181-1 Product Quality Operational Manual and local regulatory requirements.
• Be the backup of the Product/MAH Quality Representative in The Netherlands

As the Product Quality Associate you:

• Support Product quality related matters and report on quality issues within the affiliate in conjunction with the Product/MAH Quality Representative (PQR), the Regional Quality Leader (RQL) and Responsible Person (P) as needed.
• Promptly elevate and consult as needed to PQR, RQL and/or to the broader organization via notification to management for final resolution.
• Support that a Product Quality Management System is implemented but not limited to:
  • Local Product Quality Manual and SOP reflecting local regulations and Lilly requirements
  • Deviation system to manage Product Quality issues (ensuring they are investigated, documented with appropriate CAPAs)
  • Change Control system
  • Notification to Management system
  • Monitoring and trending of quality systems
  • Affiliate Quality plan
  • Self-Inspection and inspection
  • Product Complaint system
• Keep appropriate records of any delegated duties.
• Support external party management, including service providers that handle or distribute products, meet quality expectations as per local and Lilly requirements, and where applicable, local controlled drug and Lilly-designated Special Security Substance expectations.
• Support that suppliers and customers are approved.
• Support that the final disposition of returned, rejected, recalled, or falsified products in conjunction with the RP and as per CQP 181 – 1 requirement.
• Support that a system is in place to manage physician-sampling programs according to product quality, and where applicable, local controlled drug and Lilly-designated Special Security Substance requirements.
• Ensure process to manage serialization alerts, reports of suspect or tampered or counterfeited products from product complaints, adverse events, or returned product is in place as per local regulations and Lilly standard.
• Support Product Complaint Process to ensure that product complaints from customers are handled according to Local legislation and local/global procedures.
• Ensure acceptability of promotional items that have the potential to directly impact the product quality or patient safety.
• Work with the regional quality leader and Responsible Person to assure suitable area(s) and process(s), are used for any additional operations to be carried out on finished product prior to distribution (product customization: e.g., addition of stickers, stamping, special packaging for refrigerated items).
• Ensure in conjunction with PQR and Responsible Persons appropriate communication with Regulatory Authorities about product quality matters and MAH responsibilities, including but not limited to product shortages, counterfeit and quality defects.
• Ensure that any agreement into which the marketing affiliate enters receives appropriate quality oversight according to LQS
  102 – Quality Management of Collaborations with External Parties.
• Support monitoring for local regulations to ensure…