Global Associate Director

**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.

TAPI Global Quality SME and Partner with R&D department and Analytics Science and Technology (AS&T).

Responsible for establishing, maintaining, and continuously improving the quality framework across TAPI’s Global R&D organization, and Analytical aspects in global and local MS&T (AS&T). This includes oversight of procedures, all GxP-related activities, regulatory compliance, Analytical Activities and quality system implementation and related Projects management at global level.

Responsible to ensure that R&D and AS&T operations align with internal standards, global regulatory expectations, and customer requirements, particularly in the context of API development and CDMO services.

**MAIN ACCOUNTABILITIES**:

- Act and behave in accordance to TAPI’s values and leadership standards.

**1. R&D Quality System Development & Oversight**
- Lead the design and implementation of a robust Quality Management System (QMS) tailored to R&D operations.
- Ensure alignment with cGMP, ICH, and other applicable regulatory guidelines.
- Define and maintain R&D-specific quality procedures, standards, and policies.
- Serve as the quality lead for R&D in global quality councils and governance forums.

**2. Gap Analysis & Compliance Monitoring**
- Conduct comprehensive gap assessments across R&D and AS&T functions to identify compliance risks and improvement opportunities.
- Develop and govern remediation plans to close identified gaps.
- Monitor adherence to regulatory and internal quality requirements across all R&D activities.

**3. AS&T**
- Governing of the implementation of the regulatory and internal requirements and standards
- Management and governing of improvement and optimization projects at global and multi-site levels

**4. Oversight**
- Plan and execute internal audits of R&D operations.

**5. Training & Quality Culture**
- Develop training programs and instruct R&D quality representatives and champions.
- Promote a proactive quality culture through coaching, mentoring, and engagement.

**Qualifications** Formal Education**
- Bachelor’s or Master’s degree in Chemistry, Pharmacy, Biotechnology, or related scientific discipline.
- Minimum 10 years of experience in Quality Assurance within the API manufacturing industry, with at least 5 years in API development, Analytical Chemistry and Multidisciplinary Project management and Governance.
- Strong knowledge of GxP, ICH guidelines, global regulatory expectations and Pharmaceutical Ingredients Development Industrial Practices.
- Proven experience in quality system implementation, gap analysis and oversight processes.
- Excellent communication, leadership, and cross-functional collaboration skills

**Practical Knowledge and Experience**
- ** Working experience in API/Pharma companies in a similar role is a must.**:

- Ability to work with external vendors/suppliers and customers.
- Demonstrates continuous professional development.
- Advanced leadership skills, business strategy, accountability, proven experience leading and motivating global, cross-functional teams.
- ** International experience is a must.**:

- Advanced experience in working with matrix environment.
- Advanced negotiation skills.
- Advanced knowledge and experience in Problem Solving.
- Advanced communication skills - written and verbal.
- Advanced agility leadership and teamwork skills.
- ** Must be able to travel based on business need; up to 30% when critically required (domestic and international).**

**Professional competencies**
- Energetic and committed to continuous improvement.
- Effective negotiation skills, strong interpersonal skills, excellent presentation skills.
- Strong project and change management skills.
- Proactive orientation, self-motivated, flexible, and innovative way of thinking.
- Ability to work with various organizational leadership levels and in a team environment across multiple roles.
- Good software knowledge (MS Office, Priority, Trackwise)
- Multi and Intercultural sensibility.

**Languages**
- ** English Proficiency is a must**:

- Proficiency in the local language would be preferable (Italian)

**BUSINESS EXCELLENCE**:

- ** Building Customer Focus**
- Addresses multiple customer issues in a timely manner.
- Effectively adjusts plans to meet changing needs