Associate - Product Quality - NL

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Purpose of the position

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

Key elements of the Role

Essential Functions

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 escalate 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 our 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 LQS102 – Quality Management of Collaborations with External Parties.
• Support monitoring for local regulations to ensure appropriate implementation of any local or European laws/guidance with potential product quality impact.
• Provide support to any project with Product Quality impact at affiliate level.
• Support the Responsible Person on any recall or mock recall operations for medicinal products, devices and promotional materials with Product Quality impact.
• Support with the implementation of any project with Product Quality impact at affiliate level.
• Support ELEXSA NL Responsible Person on activities in relation to obligations/responsibilities resulting from the ELEXSA NL wholesale license.   

Profile

Technical Skills

• Relevant knowledge and experience related to the manufacturing and distribution of medicinal products
• Relevant knowledge of Dutch and European (EMA) legislations.
• Knowledge of IT systems (SAP, VeevaVault, Success factors….).

Soft Skills

• Capability to carry responsibility, work under pressure, analysis and judgment, analytical skills, and flexibility.
• Effective communication skills.
• Proven ability to establish internal and external relationship and influence globally diverse groups at all levels in a complex regulatory environment.
• Be able to anticipate and resolve complex technical issues.

Education

• Pharmacy degree or bachelor's degree in physical or biological science
• Eligible as Responsible Pharmacist according to Dutch Regulations

Previous Experience

• Minimum of 2-3 years industry related experience in multiple areas that may include quality, technical services, regulatory affairs, product development or manufacturing operations.

Languages

Fluent Dutch and English levels, written and verbal

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