Quality Manager

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.

Purpose of the position

• Ensure the implementation and execution of Lilly Global Quality Standards in particular CQP-181-1 in the marketing affiliate Hungary.
• Ensure the implementation and execution of an adequate Product Quality System based on Lilly Quality Standards and any applicable local regulations.
• Collaborate with Regional Quality Team to seek advice, inputs and guidance in all related quality matters/projects.

The Quality Manager fulfils the following functions:

• QA manager and Product Quality Representative (PQR) of Lilly Hungária Ltd.,
• Anti - Counterfeit contact, Responsible Complaint Person (RCP), Supplier relationship manager for distribution for Hungary, Cyprus and Malta for quality matters
• Responsible Person for Hungary.

Key elements of the Role - Essential Functions

The Quality Manager Of Lilly Hungaria Ltd., Manages All Quality Activities Of The Hungary Affiliate In Compliance With Eu Gdp, 53/2004 Distribution Law Of Hungary And Lilly Global Quality Standards.

The Product Quality Representative (Pqr) Manages All Product Quality Related Matters Of The Affiliate, And Will Advise, Decide And Escalate As Follows:

• Making decision on returned, rejected, recalled products in Hungary.
• Making decisions on falsified medicines.
• Prepares and maintain the local Quality Manual to describe the quality system of the affiliate. Improves the quality/technical standards for all Lilly activities, implementing the local rules and relevant Lilly standards and guidelines.
• Works with the Affiliate Management to ensure a product quality system in place and current with applicable regulations.
• Develop the local Quality Plan and ensure actions closure.
• Keeps the local Affiliate management and the RQL informed in issues and progress.
• Delivers quality related training to employees of Lilly Hungária Ltd. where appropriate in cooperation with group leaders.
• Ensure that all quality related failures and/or incidents are evaluated and escalated if needed to the RQL.
• Ensures any new business deal at the Affiliate  are handled according to the relevant quality standards.
• Works with the RQL to assure the right process in case of  product customization.
• Provide  quality oversight to  promotional materials with GMP impact developed by the Affiliate.
• Making independent decisions in all quality related affairs.
• Ensures that a process is in place to manage product complaints. Handling complaints in accordance with valid procedures and Lilly standards.
• Provides support to the compliance project of the Lilly Hungária Ltd.
• Provide quality ofversight to the management of free medical samples at Lilly Hungária Ltd.

Activities related to distribution and warehousing activities in the Hungarian market:

• Act as Responsible Pharmacist for Hungary, and authorized to put medicines in sellable stock (53/2004 local decree).
• Manage and maintain  local SOPs and documentation system.
• Provide quality oversight to the Lilly consignment warehouse in Hungary ensuring compliance with GDP/ GMP requirements and Lilly standards.
• Perform local batch release of medicinal products and medical devices received.
• Performs internal quality assessments to the Lilly consignment warehouse service provider and customers (distributors, wholesalers).
• Approves  local Lilly quality procedures, agreements , , and reports as needed. Review and approve calibration/qualification and validation documents at Lilly consignment warehouse.
• Review and ensure regional quality revision of all communication with the National Center for Public Health and Medicines (NNGYK) and other local authorities in both countries related to product quality issues.
• Responsible for the proper handling of SSS products designated by Lilly if applicable.
• Ensures that a process is in place to manage local recall activities.
• Prepares report and trend analysis for the Affiliate management and for the RQL as defined in the Quality Manual.
• Ensures compliance with serialization requirements for distribution activities.
• Create and manages change controls and deviations.
• Prepares and participates in Health Authority inspections, internal and external audits.
• Provides audit readiness and follow up on audit findings and health authorities inspections.
• Prepares, implement and follow-up of corrective and preventive actions (CAPA).
• Ensures necessary repackaging as required. Controls and releases goods that have been re-worked in Hungary.
• Applies for formal defect exceptions in the name of Lilly Hungária Ltd. from the Hungarian authorities when necessary. Obtains all required regulatory authorizations formal defect, final sample, etc.
• Keeps contact with relevant departments of the NNGYK in collaboration with the RQL.
• Acts as the supplier relationship manager for the logistic service provider in the local markets for quality matters.
• Acts as local anti-counterfeiting contact at Eli Lilly Corporation.
• Carry out the GMP and GDP responsibilities on behalf of the MAH.
• Provide quality support to  projects impacting quality, GDP/ GMP such as:
• Warehouse and Distribution management: distribution agreements & Audits
• Transport providers management: quality agreements and audits
• Cold Chain Assurance
• Serialization
• Customization initiatives
• External parties for GMP activities
• Provides audit readiness and follow up on audit findings and health authorities inspections.
• Prepares, implement and follow-up of corrective and preventive actions (CAPA).
• Warehouse and Distribution management: distribution agreements & Audits
• Transport providers management: quality agreements and audits
• Cold Chain Assurance
• Serialization
• Customization initiatives
• External parties for GMP activities

Technical Skills

• Expertise in Quality Assurance and distribution of medicinal products and medical devices.
• Expertise in GMP/GDP requirements.
• Knowledge of Affiliates IT systems (SAP, TrackWise, QualityDocs, Success Factor, etc).

Soft Skills

• Excellent communication skills
• Ability to teamwork
• Proven leadership skills
• Problem solving attitude
• Strong conduct of integrity

Education

• Bachelor’s degree in Pharmacy

Previous Experience

• Minimum of 5 years’ industry related experience in quality and distribution of medicinal products and medical devices.

Languages

• Hungarian (native), English fluent.

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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