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Purpose of the position
As the Product Quality Representative (PQR) for Belgium/Luxemburg and The Netherlands (BENELUX):

• Be the contact for the Marketing Affiliates organization about the product quality and provide quality oversight for Eli Lilly products and medical devices distributed within BENELUX 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.

As the Marketing Authorization Holder (MAH) Quality Representative for Belgium/Luxemburg:

• Ensure that the requirements of the EMA concept paper on Good Manufacturing Practice and Marketing Authorization Holders are implemented

As the Recall Coordinator for BENELUX:

• Ensure the execution and coordination of recalls/product defects of Eli Lilly products (including medical devices and promotional materials with Quality impact) as required and in conjunction with Responsible persons.

Key elements of the Role - Essential Functions

As the Product Quality Representative (PQR):

• Coordinate and manage all product quality related matters and advise, decide, and report on all quality issues within the affiliate. Promptly escalate and consult as needed to the regional quality leader, the Responsible Persons as needed and/or to the broader organization via notification to management for final resolution.
• Ensure 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
  • Product Complaint system
• Keep appropriate records of any delegated duties.
• Ensure that 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.
• Ensure that suppliers and customers are approved.
• Decide on the final disposition of returned, rejected, recalled, or falsified products in conjunction with the Responsible Persons and as per CQP 181 – 1 requirement.
• Ensure 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 that a 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.
• Ensure acceptability of promotional items that have the potential to directly impact the product quality or patient safety,
• Work with the regional quality leader 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 Responsible Persons appropriate communication with Regulatory Authorities about product quality matters and MAH responsibilities, including 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
• Ensure 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

As the Marketing Authorization Holder (MAH) Quality Representative:

• Work in close contact with the person responsible of the preparation of the APR (Annual Product Review) and approve APR for all products for which Lilly Belgium/Luxemburg is the MAH.

As the Recall Coordinator:

• Coordinate and promptly execute in conjunction with Responsible Persons any recall or mock recall operations for medicinal products, devices and promotional materials with Product Quality impact.

Profile
Technical Skills

• Relevant knowledge and experience related to the manufacturing and distribution of medicinal products
• Relevant knowledge of the EMA concept paper on Good Manufacturing Practice and Marketing Authorization Holders.
• Relevant knowledge of Dutch, Belgian, Luxemburg and European (EMA) legislations.
• Knowledge of IT systems (SAP, Trackwise, Quality docs, Success factor).

Soft Skills

• Capability to carry responsibility and work under pressure
• Strong judgment and analytical skills
• Flexible
• 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.

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
Good French, Dutch and English levels (written and verbal).

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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