Quality Assurance 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.

The opportunity

We are looking for a qualified and motivated candidate for the role of Quality Assurance Manager, based in Sofia.

How you’ll spend your day

• Ensure compliance with all applicable cGMP directives, regulations, and guidelines to maintain the high quality of pharmaceutical products.
• Lead and oversee deviation investigations, ensuring compliance with Teva corporate procedures and local quality procedures.
• Perform impact and risk assessments for critical quality events.
• Assess and categorize deviations and determine the impact on affected batches.
• Coordinate with Teva affiliates regarding deviations that may affect product deliveries.
• Review and evaluate deviation reports from contract manufacturers, assessing their potential impact on the batch release process in collaboration with the responsible Teva release QP.
• Participate in regulatory inspections, Teva corporate inspections, and internal self-inspections within the scope of responsibility.
• Collect and analyse quality data and documentation, prepare documentation packages for Quality Alignment Meetings (QAMs) and Market Action Committees (MACs) in accordance with approved templates, and prepare Health Authority (HA) notification letters.
• Monitor and trend deviations and quality metrics to identify improvement opportunities.
• Prepare and report KPIs related to quality events and deviation management.
• Author and maintain local SOPs related to critical quality issues, deviation management, CAPA, and CAPA effectiveness.

Your experience and qualifications

• Experience in pharmaceutical manufacturing/validation/other related experience and/or in analytical control and regulatory compliance
• Master’s degree in pharmacy, chemistry, similar natural sciences, engineering or at least several years working experience in the quality assurance area
• Understanding of the drug manufacturing process. Knowledge of generics and branded product development is a plus
• Good interpersonal and communication skills, as well as organizational skills
• Ability to communicate complex issues, decision-making, problem-solving skills
• Proficient in written and spoken English
• Proficiency in MS Office, SAP, Veeva

How We’ll Take Care of You 

At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community.  

When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way. 

Make a difference with Teva Pharmaceuticals

If this sounds like the right opportunity for you, please 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.