Qualified Person (QP) at Lilly

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.

Position Overview/ Your Mission:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for an experienced Qualified Person (QP) to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The QP is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a manufacturing facility. These provisions include ensuring that the batch has been produced according to appropriate standards and has successfully passed all required tests.

Why This Role Is Exceptional

Build from the Ground Up: Be part of the foundational team establishing a new site.

Define the Culture: From day one, you will play a pivotal role in shaping the quality culture and setting the standards that will define our operations for years to come.

Lead with Purpose: Your work will directly impact the delivery of life-changing medicines.

Innovate Daily: Work with cutting-edge technologies in a dynamic, forward-thinking environment.

Personal and Professional Growth: We are committed to your development. Through our "Corporate Lilly University," you'll have access to a wealth of professional development opportunities, ensuring you can grow and advance your career on a global scale.

Attractive Benefits: Enjoy a competitive salary, an excellent company pension plan, and a range of individual benefits designed to support your well-being and financial security. We value your contributions and reward your dedication.

If you're ready to make your mark, inspire excellence, and help improve lives through quality, we would love to hear from you.

Responsibilities:

1/ Certification and Release of Finished Batches

Confirms, certifies, and releases batches of products manufactured, ensuring all manufacturing steps have been performed in compliance with GMP, the marketing authorization of the relevant product, defined procedures, and current regulations.
Confirms batches of products intended for clinical trials.
Approves batch certificates.
In case of non-compliance detected at their level, decides on necessary actions.
Ensures periodic monitoring of the quality review activity for semi-finished and finished batches.

2/ Quality and Regulatory Monitoring

Continuously updates knowledge by staying informed of technical, regulatory, and scientific developments.
May consult regulatory dossiers for the marketing authorization of products they confirm, certify, and release.
May consult quality contracts necessary for the confirmation, certification, and release of product batches, and participates in their updates.
Ensures documented oversight of imported products and active substances.

3/ Quality Assurance

Performs analysis of corporate standards and participates in their implementation on site.
Participates in the implementation of new regulations.
Acts as approver and/or reviewer of procedural documents related to their activity.
Approves regulatory specifications of manufactured products in the LIMS system.
Approves in SAP the list of countries registered for finished product codes.
Acts as reviewer for the Annual Product Review (APR) of the Fegersheim site, ensuring the quality of the analysis and conclusions.
Conducts impact analyses in the change management system related to their area of expertise.
Verifies the application of the quality system in and outside the quality department (especially through audits).
Responsible for the annual stability strategy on site.
Responsible for the annual visual inspection strategy on site.
Approves stability protocols.
Represents Quality Assurance at the monthly CCRC Committee.
Communicates with subsidiaries/other manufacturing sites regarding the decision to quarantine already shipped batches.
Prepares ANIRs (Additional New Information Reports) as part of Annual Reports (e.g., US, Mexico, etc.).

4/ Technical Support

May be responsible for implementing changes related to their activity.
Conducts impact analyses of change controls related to their area of expertise.
May review/approve deviations and change controls.
Participates in the major deviations and change controls committee.
Reviews quality contracts with suppliers (active ingredients), subcontractors, and clients (Lilly subsidiaries and external clients).
Coordinates batch traceability requests.
Coordinates with the delegated pharmacist for batch recall simulation exercises.
May participate in Rapid Investigation Groups (GIR) in case of major investigations.
Conducts regulatory monitoring to maintain site compliance with pharmacopoeias (outside the laboratory): analyzes publications, communicates changes to relevant departments.
Drafts and is responsible for submitting the status report and teledeclaration of MPUPs (pharmaceutical raw materials) to the ANSM.
Determines the need to submit Modification Requests for the pharmaceutical establishment to the ANSM.
Drafts Modification Requests for the pharmaceutical establishment.
Collaborates with the Responsible Pharmacist, QPs from the affiliates to verify the accuracy and relevance of data submitted to Authorities.

5/ Audit/Inspection

Conducts or participates in internal audits according to the program defined by the internal quality audit manager and follows up on action plans.

May participate in and/or prepare quality audits at suppliers/subcontractors/France subsidiary as per the defined program.
Interacts directly with auditors/inspectors during audits/inspections concerning their area of expertise.
Acts as a member of the escort/documentation room/preparation room during audits/inspections.
May coordinate the drafting of responses to audit/inspection observations.

Basic Requirements:

Education:
- Completed degree in pharmacy and licensure as pharmacist; Expert knowledge as per §15 of German Medicinal Products Act (Arzneimittelgesetz, AMG)
- Qualified Person as per §14 of the German Medicinal Products Act (EU Qualified Person)
- If applicable: Supervision of an adequate importation process of medicinal products from non-EU countries in compliance with §72 of the German Medicinal Products Act (AMG) and the EU GMP Annex 21
Professional Experience:
At least two years' practical experience in the field of qualitative and quantitative analysis and other quality testing of medicinal products (i.e. Expert Knowledge as per §15 AMG).
Language Skills:
Fluent in spoken and written German and English

Additional Skills/Preferences:

Profound knowledge of applicable national and European drug legislation, cGMP/GDP guidelines as well as relevant national and international requirements of pharmaceutical industry with focus on distribution of medicinal products
Profound knowledge of importation requirements from third countries into the European Union as per EU GMP Annex 21 and Union Customs Code (UCC) as well as testing & release requirements as per EU GMP Annex 16

In-depth knowledge of pharmaceutical legislation, quality management systems, and the professional obligations of a quality manager.
Good understanding of pharmaceutical manufacturing and supply chain.
Leadership.
Decision-making ability.

Additional Information:

Primary location is Alzey, Germany
On-site presence required
Ability to travel (approximately 10-20 %)
Ability to work overtime as required
May be required to respond to operational issues outside of core business hours and days (on-call duty)

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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