**FAVOR DE POSTULARSE ÚNICAMENTE SI CUMPLES CON EL PERFIL**

**Only profiles, that align 100% to the description will be consider, we beg you not to apply if the position does not match**

Company Description

At TAPI, we're not just a company—we're a community committed to advancing health from the core. As the world's leading supplier of active pharmaceutical ingredients (APIs), we partner with 80% of the top 50 global pharmaceutical companies. With a legacy spanning over 80 years and a portfolio of more than 350 products, as well as custom CDMO services, we're shaping the future of health worldwide.

Our strength lies in our people—a team of over 4,200 professionals across 13 state-of-the-art facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Together, we innovate, solve problems, and deliver excellence. Join us and be part of a mission that transforms lives.

Job Description

Job Purpose:

The Site Quality Head (SQH) is responsible for ensuring the design, implementation, and continuous improvement of the site's Quality Management System (QMS), in full alignment with TAPI's global quality standards and applicable international regulations. This role is pivotal in embedding a strong quality culture, assuring regulatory compliance, and delivering operational excellence across all functions.

Key Responsibilities:

1. Lead and develop the Quality Assurance, Quality Control, Analytical Support, and Compliance functions, fostering a culture of accountability, empowerment, and continuous quality improvement.
2. Ensure that all site quality systems are aligned with international GMP/GDP standards and corporate quality policies, including regular monitoring of evolving regulations and their implementation.
3. Guarantee that all products manufactured at the site meet current regulatory requirements for all target markets where TAPI operates.
4. Identify, assess, and address quality risks, system gaps, and performance improvement opportunities through a robust Quality Improvement Plan and proactive risk management.
5. Track and optimize site-level Quality KPIs, using data-driven insights to drive process excellence and operational efficiency.
6. Ensure site inspection readiness at all times. Lead regulatory inspection planning, execution, and response, ensuring timely closure of any regulatory commitments.
7. Champion a continuous improvement mindset throughout the organization, driving optimization of systems, methods, and processes to elevate productivity and quality performance.
8. Ensure the Quality, Safety, and Efficacy of all products and third-party services through well-defined and actively managed Quality Technical Agreements.
9. Drive cross-functional solutions and lead quality-related changes, ensuring full alignment with applicable regulatory and global requirements.
10. Serve as the official Sanitary Officer for TAPI at the site level. Lead budget planning and management for the Quality function.
11. Actively contribute as a member of the TAPI Global Quality Leadership Team, collaborating on corporate initiatives and supporting the global quality network.

Soft Skills:

• Collaborative and influential team player.
• Decisive, inspiring leader who can align technical rigor with business priorities.
• Strong communicator who builds trust and clarity across levels and functions.
• Agile, resilient, and committed to fostering high-performance teams.

Travel:

Up to 10% international and domestic travel may be required.

Qualifications

Basic Requirements:

Education: Academic degree in Chemistry, Pharmaceutical Sciences, or a related discipline.

Experience: Minimum of 7 years of progressive leadership experience managing Quality Units in a GxP-compliant environment within multinational API or pharmaceutical organizations.

Capabilities:

• Proven leadership in quality management (minimum 7 years in senior roles).
• Demonstrated assertiveness, a systematic and strategic mindset, and strong cross-functional influence.

Technical Expertise:

• Deep understanding of current GxP regulations and global quality standards (EU, US, ICH, local).
• Broad and integrated knowledge across Quality Assurance (QA), Quality Control (QC), Quality Systems, Compliance, Documentation, and Analytical Support.
• Strong command of regulatory requirements in API manufacturing, with emphasis on FDA expectations and inspection readiness.
• Demonstrated ability to design, implement, and sustain manufacturing quality standards aligned with corporate and regulatory frameworks.
• Preferred: Expertise in Operational Excellence, Lean Management, or Project Management methodologies.

Languages:

• Fluent Spanish (native level).
• Advanced English proficiency (verbal and written).

**FAVOR DE POSTULARSE ÚNICAMENTE SI CUMPLES CON EL PERFIL**

**Only profiles, that align 100% to the description will be consider, we beg you not to apply if the position does not match**

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