Teva Quality Manager/ Responsible Person 

Romania, Bucharest 

280929147

• Acting as the Responsible Person (RP), ensuring full compliance with GDP, national and EU pharmaceutical regulations, and narcotic distribution laws.
• Independently overseeing market release, recalls, and complaints related to medicinal products.
• Leading quality management processes, including audits, SOPs, CAPAs, change control, and documentation systems.
• Communicating directly with national health authorities and hosting inspections with full readiness at all times.
• Maintaining licenses and authorizations related to medicinal and narcotic products, including reporting to authorities.
• Providing strategic quality guidance and partnering closely with the General Manager and cross-functional commercial teams.
• Leading and executing risk management activities across the distribution chain.
• Participating in European-level quality councils and ensuring implementation of regional initiatives locally.
• Ensuring continuous GDP training, quality awareness, and inspection readiness.
• Being the key local quality contact for both internal stakeholders and external regulatory bodies.

• Master’s Degree in Pharmacy, Medicine, or Biology (Pharmacist license mandatory); advanced degrees are a plus.
• Minimum 3 years of experience in a RP, QP, or QA Manager role in a pharmaceutical company, ideally in a large international organization.
• Proven ability to work independently, with full ownership of RP and QA responsibilities.
• Strong understanding of GDP, GMP, and Romanian/EU legislation including those related to narcotic substances.
• Experience managing health authority inspections, quality systems, and regulatory submissions.
• Excellent communication skills and ability to influence at all levels of the organization.
• Track record of implementing quality systems, continuous improvement, and issue escalation.
• Fluent in English; Romanian language proficiency is essential for regulatory communications.
• Strong problem-solving, decision-making, and risk assessment capabilities.

• Competitive compensation package aligned with experience.
• Benefits package: meal vouchers, healthcare subscription to a private clinic.
• Highly professional team and organizational culture with strong values.
• Professional development within the company.

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