Responsible Person GDP, Quality Senior Manager Commercial Di

## 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.
## Main Responsibilities

- Perform or ensure the market release of product batches purchased from EEA countries based on batch release and transport documentation, including serialization, ensure FMD alerts are properly assessed and acted upon as appropriate

- Maintain and update the Wholesale Distribution Authorization (WDA) and ensure GDP compliance of the approved distribution center.
- Prepare and submit required reports on distributed products, medical samples and narcotic products to the authorities, according to current legislation.
- Manage complaints, recalls, returned products and destruction of obsolete goods, including investigations and corrective actions with manufacturing sites and Pharmacovigilance where necessary.Ensure MAH and GDP compliance and promote quality culture within the commercial unit.

- Create and maintain SOPs and Working Instructions as per Teva standard and in compliance with national regulation
- Ensure initial and continuous GDP training implementation and maintenance at a local level

- Support continuous improvement, lead Local Quality Management Review and participate in European Quality Councils.
- Ensure a system is in place to manage Product Quality Reviews including MAH review
- Provide the local monthly quality metrics to the European Commercial Quality
- Provide GxP guidance and quality oversight for local GxP activities.
- Manage Quality Management System activities, including complaints, recalls, change controls, deviations and CAPAs.
- Implement the process of detection, evaluation and taking of appropriate preventative measures in case of drug shortage, ensure notification of drug shortage to competent authorities
- Ensure appropriate archiving of quality documentation and compliance of GxP-related ERP activities.
- Escalate critical quality issues and ensure implementation of related action plans.
- Maintain inspection readiness for GDP, GMP and MAH requirements, host authority inspections and ensure implementation of inspection CAPAs.
- Perform internal audits and self-inspections.
- Maintain the authorization for storage and distribution of narcotic substances and products, obtain release authorization for shipments and monitor their distribution.
- Maintain high ethical and professional standards in line with the Conduct Code, FCPA policy, SOPs and Pharmacovigilance Procedures.

## Experience & Competencies

- Certificate of Free Practice issued by the Pharmacists College in Romania.
- Master’s Degree in Pharmacy, Medicines, Biology or an equivalent combination of relevant education and experience.
- Post-graduate or Doctoral degree in Pharmacy, Medicines, Biology or a related field preferred.
- Minimum 3-5 years of experience as a Quality Manager/QP/RP in a pharmaceutical company or importer/distributor;
- Knowledge and working experience with Romanian government regulations.
- In-depth knowledge of pharmaceutical Quality Compliance and GxP regulations, with working knowledge of pharmaceutical operations.
- Experience in developing and implementing Quality Systems and applying risk assessment tools.
- Knowledge of National and European legislation regarding distribution of medicines, including narcotics and medical devices.
- Proficient computer skills, including MS Office.
- Excellent English.
- Technical & Professional Expertise.

## Soft Skills

- Result-driven.
- Ability to determine stakeholders’ needs and expectations.
- Ability to adhere to determined timelines.

## 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. 
## Already Working @Teva?
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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.