QA Manager and Responsible Person - Romania Affiliate

Eli Lilly

Romania, Bucharest Onsite Quality (Jfg)

About this role

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

1. Role of the Position

Fulfils all duties of the Responsible Person as defined in the Good Distribution Practice (GDP) Guidelines:

Coordinates all wholesale distribution activities of finished pharmaceutical products and medical devices within the company in accordance with MOH Order 131/04.02.2016 (Rules regarding the establishment, organization, and operation of wholesale distributors of medicinal products for human use) and MOH Order 761/17.06.2015 (Good Distribution Practice Guidelines).
Has relevant knowledge of Law 95/2006, republished, with subsequent amendments and additions.
Ensures the implementation and maintenance of the Quality Management System as defined in the GDP guidelines and internal Lilly global standards.

2. Responsibilities

Ensures that a Quality Management System is implemented and maintained
Verifies, from a GDP/ GMP perspective, procedures developed together with Quality Assurance
Manages authorized activities
Ensures implementation and maintenance of initial and ongoing training programs
Coordinates and promptly performs medicinal product recall operations
Ensures effective handling of quality complaints
Ensures that suppliers and customers are approved
Approves subcontracted activities that may impact GDP
Ensures that self-inspections are conducted regularly according to a predefined schedule
Ensures that corrective and preventive actions are implemented
Maintains records of delegated tasks
May delegate tasks but not responsibilities
Makes decisions regarding the final disposition of returned, rejected, recalled, or falsified products
Approves reintroduction into saleable stock of returned products
Ensures compliance with all additional requirements under Art. 790 letter b) of Law 95/2006, as amended
Ensures compliance with public service obligation
Requests marketing authorizations (MA) for all distributed products
Verifies certificates of analysis, quality certificates, and their records
Is responsible for implementing the emergency plan as specified in the product recall procedure when required by competent authorities and prepares the related documentation
Verifies recorded temperature values in storage areas and transport means of suppliers, ensuring compliance with manufacturer specifications and applicable legislation
Periodically archives storage and transport condition records according to procedures
Records deviations identified during the distribution process and participates in their investigation and resolution according to the SOP for deviation management
Participates in the preparation of the risk register by identifying GDP-related risks
Ensures that all risks related to GDP/ GMP processes are identified, recorded, evaluated, and managed according to the quality risk management procedure
Ensures that change control related to GDP/ GMP activities is performed according to procedure and approves implementation of action plans
Ensures that responsibilities related to the management of serialized medicines are implemented
Ensures monthly reporting to ANMDMR of distributed medicines (electronic and/or paper format)
Submits daily SER reporting to the Ministry of Health
Periodically participates in training and professional development courses relevant to the activity
Ensures that outsourced distribution activities to the Logistics Service Provider are performed in compliance with GDP, legislation, and contractual provisions
Periodically audits outsourced activities to verify compliance with GDP guidelines
Performs periodic stock reconciliation
Records goods receipt and processes customer orders
Verifies compliance with contractual terms and conditions with customers from a GDP perspective
In case of a quality complaint, promptly notifies the supplier/manufacturer or Marketing Authorization Holder (MAH)
In case of identification of falsified or suspected falsified medicines, notifies the manufacturer/MAH and ANMDMR
Maintains records for all returned, rejected, recalled, or destroyed medicinal products
Collaborates directly with the Responsible Person of the Logistics Service Provider for the supervision and execution of subcontracted activities

3. Education: University Degree – Faculty of Pharmacy

4. Specific job requirements:

Membership certificate issued by the Romanian College of Pharmacists.
At least 5 years’ experience in Quality Assurance and as Responsible Person role (covering the handling, storage and distribution of finished pharmaceutical products and medical devices).
Hold knowledge of Law No. 95/2006, MOH Order 131/04.02.2016, GDP Guideline (Order 761/2015) and any other European and local regulation related to the distribution of finished pharmaceutical products and medical devices.
Knowledge in Quality Management Systems (policies, procedures, computerized systems, GMP/ GDP records, third-party management, regulatory inspections).

5. Additional Skills/Preferences:

Proficient in using Quality Management software and tools (e.g SAP, Veeva Vault, Success Factor, etc).
Excellent communication skills.
Capability to carry responsibility, work under pressure, strategic thinking, analytical skills and flexibility.
Proven leadership skills.
Problem solving attitude.
Strong conduct of integrity.

6. Languages: Romanian (native); fluent in written and spoken English.

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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