3rd Party Quality Operations Manager - ExM (Temporary)

We are Teva

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

The opportunity

We are currently looking for a motivated professional for the position of 3rd Party Quality Operations Manager – ExM (Temporary) based in Sofia.

About the position

The role is accountable to guarantee that current pharmaceutical standards, legal regulations and approved registrations are implemented for the production and the controlling of Third Party manufactured products. This position reports to Quality Relationship Manager (Assoc Director).

How you’ll spend your day

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 ssurance.
• 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 ExM 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

Miscellaneous

• 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.

Your experience and qualifications

• Bachelor’s degree in Pharmaceutical/Natural/Engineering science or related field
• 3+ years’ experience in quality control / analysis, production and / or quality assurance
• Must have working knowledge of cGMPs  and applicable international regulations/guidelines
• Strong computer skills including MS Office , TrackWise and SAP
• Good communication skills and resilience
• Good command of the written and spoken English language

How We’ll Take Care of You 

• 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
• Transportation allowance and flexible benefits
• Flexible working hours and the option to work from home as per company policy
• Opportunity development

Make a difference with Teva Pharmaceuticals

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

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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.