Change Control Manager

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.

Our Team, Your Impact

 

We are looking for qualified and motivated candidates for the role of Change Control Manager, based in Sofia.

 

The Change Control Manager is responsible for the Change Management Process of Third-party (TP) pharmaceutical changes in compliance with regulatory and GMP requirements to ensure that all-key projects are implemented and released at the manufacturer`s site as per plan.

 

How You’ll Spend Your Day

 

• Ownership of the Change control process
• Responsible for monitoring and following up on the status of the Change control through the lifecycle and assuring completion of all associated change activities throughout the execution and implementation of the change
• Communicates TP change requests with Contract Manufacturing and Organization Manager and Qualified Person
• Elaborate with all process involved departments - Regulatory Affairs, Manufacturing, Quality Control and Supply Chain
• Performs initial impact assessment of the change, defines the initial implementation strategy, requests and involves the respective SMEs if applicable
• Ensure that the changes are implemented in line with Good Manufacturing Practices and the regulatory requirements are met
• Coordinate change modification schedules with cross-functional teams to meet the project timelines and the release activities
• Responsible for organizing data and preparing presentation materials for assigned projects
• Change control monitoring and metrics reporting
• Monitoring and maintenance of the approved master data with the factual data for all products owned by ExM Quality EMEA

 

Your Skills and Experience

 

• Master’s degree in chemistry, pharmacy, biology or relevant to the position
• Previous experience in pharmaceutical industry
• Experience in product lifecycle management and continuous improvement
• Good knowledge of pharmaceutical quality system, regulatory framework and GMP
• Very good knowledge of change control processes and project management
• Excellent organizational skills with attention to detail
• Able to communicate efficiently with cross- functional and management departments
• Regulatory Affairs experience is an advantage
• Good expertise in Medical Device and Combination products Regulation would be considered as an advantage
• Strong knowledge of SAP and TrackWise/Veeva QMS would be considered as an advantage
• Sound knowledge of MS Office applications – Word, Excel, PowerPoint
• Very good English skills both written and spoken

 

How We’ll Take Care of You

 

• Dynamic and challenging work environment in one of the world’s leading pharmaceutical companies 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.

 

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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.