Senior Manager Quality Control

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 Responsibilities

1. Maintain and oversee the Quality Management System in laboratories, including execution of investigations into laboratory errors and quality issues, determination of root causes, and implementation of appropriate CAPAs.
2. Monitor laboratory events (LIR and OOS) and ensure compliance with relevant KPIs including cycle time optimisation, reduction in laboratory incidents, and minimisation of out-of-specification results due to laboratory error.
3. Manage the change control process for laboratory operations, ensuring all modifications are governed through the appropriate CCM procedure and aligned with current pharmacopeial and regulatory requirements.
4. Oversee qualification, calibration, and maintenance of laboratory instruments, minimising downtime whilst maintaining comprehensive documentation and records.
5. Manage laboratory licensing, vendor agreements, and quality agreements to ensure effective operational partnerships and compliance.
6. Supervise wet chemistry, stability, and microbiology teams to support timely analysis of finished products, intermediates, and raw materials whilst meeting site KPIs and business expectations.
7. Conduct audit management activities, respond to audit observations and customer queries, and track compliance report completion for internal and external audits.
8. Develop and deliver training programmes to ensure laboratory personnel are adequately qualified for their roles, maintain training records, and identify overdue or periodic training requirements.
9. Promote a quality culture within the laboratory, establish data integrity awareness, and implement appropriate controls to prevent data integrity issues.
10. Ensure compliance with local and global EHS KPIs, conduct safety-related GEMBA walks, and maintain availability of trained emergency response and first aid personnel across all shifts.

Qualifications

Experience Level: 13-18 Years
Industry Experience: API Experience is required
Qualification: M.Sc. in Chemistry

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!