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External Manufacturing and Supply Organization (EMSO) Quality Operation Manager

Date: Jun 23, 2022

Location: Sofia, BG, 1407

Company: Teva Pharmaceuticals

Company Info


Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 40,000 professionals, committed to improving the lives of millions of patients. Learn more at


In August 2016 Actavis has been acquired by Teva Pharmaceutical. In Bulgaria we are the largest employer in the pharmaceutical industry with near 1700 employees in the two manufacturing plants (Dupnitsa and Troyan); sales and marketing organization and in a number of global corporate functions based in our country. 
As a Teva company, in October 2020 Actavis has started the process of re-branding and anticipating the Teva brand.


We are looking for qualified and motivated candidate for the role of EMSO Quality Operation Manager based in Sofia, Bulgaria.


Primary purpose of the position


Collaborates with suppliers to assure that current pharmaceutical standards, legal regulations and approved registrations are implemented for the production and the controlling of Third Party manufactured products. Monitors supplier performance and supports efforts to develop and implement changes to improve the production process and analytical methods/ specifications. Follows up with suppliers on quality deviations and ensures that solutions are identified and implemented. Support Commercial Quality in the local markets in all quality related aspects.


This role focus areas will be


Product management
• Supervise the entrusted products through the entire life cycle with regard to pharmaceutical quality.
• Taking actions needed to assure the products quality and compliance. In addition, initiation, coordination, supervision and functional assessment of activities that are carried out by the relevant expert team for this purpose


Supplier Management
• Act as an internal and external contact person for all issues concerning the pharmaceutical quality of third party manufactured products. Coordination and controlling of all GMP relevant documents with regard to manufacturing process, quality control and quality assurance.
• Support of the Quality Relationship Manager


Change Management
• Support/ perform the initiation, coordination and evaluation of new product introductions and product changes (change control) and check for completeness the variation packages/documentation necessary for submission to ensure projects success.
Supplier Qualification (on-going)
• Maintains the regulatory compliance of suppliers with EMA authorities by maintaining up to date the List of Approved Vendors for the allocated vendors and performing all associated activities (related to audits, inspections and QTA’s)
• Support the execution of the QA Due Diligence of New and Existing Contract Manufacturer
• Review and Authorize Master Documents (CoA, Manufacturing Description, Manufacturing Instruction, Master Batch Record, Stability Schedules, Analytical Methods, Specifications etc.) in order to assure regulatory compliance on the supplier’s level.


Quality Technical Agreements
• Support the negotiation, preparation and approval of new QTA’s ensuring the compliance with the applicable Teva standards and regulations.
• Perform/ support periodic reviews of the QTA’s and amending previously existing Quality Agreements on an as needed basis


Technical Visits/Audits
• Support preparation and execution of regular audits/ technical visits to the entrusted vendors.
• Support inspection readiness at the relevant suppliers as per alignment with EMSO  and Global Quality
• Support Inspection readiness at the site of employment


Review of Product Quality Reports (PQRs)
• Support the initiation & Oversight on PQRs for medicinal products manufactured by 3rd parties compiled by the vendor & Global Quality Services (PQR team) in order to insure that all products in her/his portfolio are included in the PQR planning.
Deviations and Critical Quality Incidents:
• Support the necessary investigation and closure of deviations
• Support in all activities related to management of Critical Quality Issues


• Support the creation and maintenance of standard operational procedures according to Teva standards and in line with applicable legislation. Follow the SOPs relevant for her/his activities.
• Perform other duties as assigned and agreed.


Main Requirements


•    Degree in Pharmacy, Sciences, Engineering or similar with at least several years working knowledge as quality assurance officer 
•    3 or more years’ experience in pharmaceutical manufacturing/ validation/ other related experience and in analytical control, quality assurance and regulatory compliance 
•    Good interpersonal and communication skills as well as organizational skills
•    Understanding of the drug manufacturing process and analytical methods and knowledge of generics and branded product development is a plus
•    Ability to communicate complex issues to affected departments, make decisions to solve problems
•    Ready to work independently adn receive minimal guidance
•    Is able to acts as a resource for colleagues with less experience
•    Experience to lead the work of project teams and train junior staff
•    Orientation to achieving results and attention to detail
•    Proficiency in MS Office, SAP and Track Wise®, EDMS 
•    Good in written and spoken English


We Offer


•    Dynamic and challenging work environment in one of the world leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria
•    Competitive remuneration bound with performance
•    Additional healthcare insurance
•    Transportation allowance
•    Flexible working hours and option to work from home as per the company policy
•    Opportunity for development


If this sounds like the right opportunity for you, send us your CV in English.

Please, kindly note that only shortlisted applicants will be contacted.  All personal data is protected by law and will be treated in confidence.


Already Working @TEVA?


If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.


Teva’s Equal Employment Opportunity Commitment


Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.