Site Quality Head

**Descripción de la empresa**
En TAPI, no somos solo una empresa: somos una comunidad comprometida con el avance de la salud desde el núcleo. Como proveedor líder mundial de ingredientes activos farmacéuticos (API), nos asociamos con el 80 % de las 50 principales empresas farmacéuticas mundiales. Con un legado que abarca más de 80 años y una cartera de más de 350 productos, así como servicios CDMO personalizados, estamos dando forma al futuro de la salud en todo el mundo.

Nuestra fuerza reside en nuestra gente: un equipo de más de 4,200 profesionales en 13 instalaciones de última generación en Italia, Hungría, la República Checa, Croacia, Israel, México e India. Juntos, innovamos, solucionamos problemas y ofrecemos excelencia.

Únete a nosotros y sea parte de una misión que transforma vidas.
**Descripción del empleo**
- Site Quality Head; Lead Quality Assurance, Quality Control, Analytical support and Compliance Areas, empowering employees and assuring a consistent quality culture throughout the organization.
- Ensure Site Quality System Management is aligned with International GMPs/GDPs and corporates guidelines by establishing processes to ensure periodic review of local and international regulation and its implementation in the site operations.
- Ensure all products in the market are manufacturing according to the effective regulatory requirements in the countries where TAPI distributes products.
- Address promptly potential quality risks, gaps and continuous improvement opportunities through a Quality Improvement Plan and ensure that quality risk management system is adhering to manufacturing, packaging and Distribution operations.
- Monitor and track all Quality KPIs, optimizing and searching for Operational Excellence.
- Ensure that adequate regulatory inspection preparation and management plans are in place to assure to be ready all the time for Regulatory Inspections and regulatory commitments are tracked and closed on time.
- Establish a continuous improvement culture fostering optimizations in processes, systems and methods for increasing productivity.
- Ensure Quality, Efficacy and Safety of all the products and/ or outsourcing services are clearly defined through Quality Technical Agreements.
- Designated as Qualify Person for TAPI and manage the financial resources and budget of the Quality

**Requisitos**

Education: Academic degree in Chemistry, Pharmaceutical or equivalent

Experience: Minimum of 10 years of experience on GxP environment in multinational API or Pharmaceutical Industry

Exposure to international working environment

Capabilities: Assertiveness, systematic approach and Minimum of 10 years in leadership roles in the quality area.
- Sound knowledge of current GxP regulations and guidances (EU, US, ICH)
- Knowledge, understanding, and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, Documentation etc.
- Knowledge of regulatory standards and guidance in API industry and expectation of Global Regulatory Bodies, specifically FDA
- Knowledge of Quality Systems and Manufacturing Operations
- Strong ability to implement and follow up on quality manufacturing standards and procedures to comply with corporate policy and regulatory requirements.
- Ability to perform risk management and clear and timely decision making
- Leadership skill - strong ability to lead, influence and manage
- Ability to promote continuous process improvement
- Advantage -knowledge of Operational Excellence, Project Management / Lean Management tools

Language: Advanced english

**Información adicional** Deja tu huella con TAPI**

Tu viaje con TAPI es más que un trabajo: es una oportunidad para generar un impacto duradero en la salud global. Si estás listo para liderar, innovar e inspirar, nos complace darle la bienvenida a nuestro equipo. Juntos, demos forma al futuro de la industria. Esperamos recibir tu aplicación y nuestro equipo de Atracción de Talento se pondrá en contacto pronto.