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.

WeareLilly

TECHNICAL SKILLS

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

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 (preferable) or bachelor’s degree in physical or biological science.
• Be eligible to be appointed as Responsible Person according to Dutch Regulation.

PREVIOUS EXPERIENCE

• Minimum of 5 years industry related experience in multiple areas that may include quality, technical services, regulatory affairs, product development and manufacturing operations.
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PURPOSE OF THE POSITION

As the Marketing Authorization Holder (MAH) Quality Representative:

• Be the contact for the Dutch Authorities in relation to obligations/ responsibilities resulting from the Lilly NL Marketing Authorizations for nationally authorized and mutually recognized products.
• Be the contact for other Lilly affiliates, and when needed their local health authorities, in relation to obligations/ responsibilities resulting from the Lilly Marketing Authorizations for centrally authorized products in Europe or, in non-European countries, when Lilly NL is registered as the MAH.
• Ensure that the requirements of the EMA concept paper on Good Manufacturing Practice and Marketing Authorization Holders are implemented and maintained within Lilly European affiliates.

As the Product Quality Representative (PQR):

• Be the contact for the Marketing Affiliates organization and the Local/Regional Quality Leader about the product quality related matters.
• Ensure that a quality system, according to Lilly global quality standards, and specially CQP 181 – Product Quality Operational Manual for Marketing Affiliates is implemented and maintained in the Dutch affiliate.

As the Recall Coordinator:

• 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 person for Dutch affiliate.

As the Responsible Person (RP) of ELEXSA NL wholesale license

KEY ELEMENTS OF THE ROLE - ESSENTIAL FUNCTIONS

As the Marketing Authorization Holder (MAH) Quality Representative:

• Coordinates and manages all activities in relation to obligations/ responsibilities resulting from the Lilly Marketing Authorizations for centrally authorized products in Europe or, in non-European countries, when Lilly NL is registered as the MAH
• Approve Annual Product Review (APR) for all products for which Lilly NL is the MAH in Europe.
• Work in close contact with the person responsible of the preparation of the APR (Annual Product Review) for EU Affiliates to ensure that the requirements of the EMA reflection paper on Marketing Authorization Holders are correctly implemented, specifically in the APR preparation.
• Ensure that quality agreements are in place and maintained with all relevant stakeholders, including marketing affiliates and manufacturing sites.

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 Dutch affiliate. Promptly escalate and consult as needed to the regional quality leader, the Responsible Person as needed and/or to the broader organization via notification to management for final resolution.
• Ensure that a Product Quality Management System at Dutch affiliate 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 and serialization alert management systems
• Physician sample
• External parties and customers management (activities with Product Quality Impact)
• Keep appropriate records of any delegated duties.
• Preparation and management of Inspections and Audits
• Ensure that service providers that handle or distribute products in Belgium, Luxemburg and Netherlands meet quality expectations as per local and Lilly requirements, and where applicable, local controlled drug and Lilly-designated Special Security Substance expectations.
• Decide on the final disposition of returned, rejected, recalled, or falsified products in conjunction the Responsible Persons and as per CQP 181 – 1 requirement.
• 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 product quality related matters as above listed for Belgium and Luxemburg markets with appropriate collaboration with Responsible Person/PQR.
• Provide support to any project or matters with Product Quality impact at Belgium, Luxemburg and Dutch affiliates level

As the Recall Coordinator:

• Coordinate and promptly execute in conjunction with Responsible Person at Dutch affiliate any recall or mock recall operations for medicinal products, devices and promotional materials with Product Quality impact.
• Provide support to Belgium and Luxemburg affiliates to any recall or mock recall operations for medicinal products, devices and promotional materials with Product Quality impact.

As the Responsible Person (RP):

• Be the contact for the Dutch Health Authorities in relation to obligations/responsibilities resulting from the ELEXSA NL wholesale license.