Senior Manager Global Quality Systems

  • Full-time

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

 

  • Draft, revise, manage distribution, archive, and lifecycle approvals of TAPI Global QMS documents.
  • Maintain TAPI global QMS documents and continuously improve global procedures.
  • Review Health Authority inspection observations and internal audit observations and capture enhancements in TAPI’s policies and standards.
  • Perform and drive gap assessments – TAPI standards vs. new/revised regulations and guidance, TAPI standards vs TAPI site Health Authority observations, TAPI standards vs other firms’ observations (as applicable).
  • Monitor the effectiveness of the TAPI Quality Management System and prepare reports to executive management, as requested.
  • Track, trend and report TAPI Quality KPIs.
  • Design and lead improvement projects for quality processes across TAPI to enhance compliance, efficiency, and customer experience.
  • Prepare global training materials and provide training sessions across the company.
  • Act as administrator in the learning management system (LMS) and design and maintain learning assignments for TAPI Global Quality colleagues and GxP training items for global functions.
  • Track regulatory trends and provide guidance on expected changes that may affect existing and future strategies.
  • Track and trend the company's regulatory commitments.
  • Perform tracking of critical vendor issues, escalate issues to management, define QRM concept and QRM templates for site assessments, when applicable.
  • Prepare data, organize and host global Quality forums.
  • Participate in projects for computerized systems upgrades by providing Quality inputs on requirements, expectations, and system integrations.
  • Define and execute strategic projects for continued compliance and increased efficiency of Quality Management Systems.
     

Qualifications

  • Degree in Pharmaceutical Sciences, Chemistry, Technology, Engineering, Healthcare, or an equivalent combination of education and experience for the functional role.
  • Minimum of 10 years of experience in the Quality unit (Quality Systems, Quality Assurance, Quality Compliance) in a pharmaceutical company.
  • Demonstrated knowledge and working experience with GMP and GDP regulations.
  • Working knowledge of API manufacturing operations is an advantage.
  • Fluent in written and spoken English.
  • Proficient computer skills in software including MS Office (Excel, PowerPoint, and Word) and quick learning ability for using new platforms and applications.
  • Open-minded and willing to collaborate with other stakeholders in the organization.

Additional Information

Make Your Mark with TAPI

Your journey with TAPI is more than a job—it’s an opportunity to make a lasting impact on global health. If you’re ready to lead, innovate, and inspire, we’re excited to welcome you to our team. Together, let’s shape the future of pharmaceuticals. Apply on top of this page and our talent acquisition team will be in touch soon!

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