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

The Site Quality Head is responsible for leading and managing all Quality Assurance (QA), Quality Control (QC), Compliance, Validation, and Quality Systems activities at the API manufacturing site. The incumbent will ensure that all operations comply with current Good Manufacturing Practices (cGMP), ICH guidelines, global regulatory requirements, customer expectations, and company quality standards.

The role is accountable for fostering a strong quality culture, maintaining inspection readiness, ensuring product quality and patient safety, and driving continuous improvement initiatives across the site.

Key Responsibilities

Quality Leadership & Governance

• Provide strategic direction and leadership for Site Quality Assurance, Quality Control, Validation, and Compliance functions.
• Act as the primary quality representative within the Site Leadership Team.
• Develop and implement site quality strategies aligned with business and global quality objectives.
• Promote a quality-first culture throughout the organization.
• Establish quality objectives, KPIs, and continuous improvement initiatives.

Quality System Management

• Maintain a quality system in accordance with current requirements of regulatory authorities, cGMP, GLP, and internal quality standards. 
• Ensure quality oversight across employees, production processes, product development activities, and logistics processes impacting product quality.
• Approve all procedures affecting the quality of intermediates and APIs.
• Ensure implementation, monitoring, and continual improvement of site quality systems.

Batch Release and Material Quality Oversight

• Release or reject APIs and intermediates for use outside the control of the manufacturing company. 
• Establish and maintain systems for release or rejection of raw materials, intermediates, packing materials, and labelling materials. 
• Approve specifications for all company materials and products. 
• Ensure materials are appropriately tested and that test results are accurately reviewed and reported.
• Review completed batch production records and laboratory control records for critical process steps prior to API release for distribution. 

Deviation, OOS, CAPA and Risk Management

• Ensure critical deviations and Out of Specification results are properly investigated, closed, and supported by appropriate CAPA. 
• Verify effective implementation and closure of CAPA actions. 
• Review, evaluate, and approve risk assessments prepared at the site. 
• Pre-notify relevant stakeholders of any circumstances that may affect product quality before product release. 

Documentation and Compliance Governance

• Review and approve master documents including SOPs, protocols, batch records, specifications, analytical records, and related quality documents. 
• Participate in review and revision of QC procedures, standard testing procedures, specifications, method validation, and cleaning validation documents.
• Ensure documentation practices are aligned with GMP and data integrity expectations. 

Laboratory, QC and Equipment Oversight

• Monitor Quality Control laboratory setup, functions, systems, and upgrades in line with regulatory requirements. 
• Ensure analytical method transfers are available and appropriate for methods used in the Quality Control laboratory. 
• Oversee selection, upgradation, procurement, installation, and qualification of laboratory equipment. 
• Monitor and approve qualification activities for equipment, instruments, and computer systems. 
• Monitor and approve calibration and preventive maintenance programs for manufacturing and laboratory equipment and instruments.

Validation and Product Quality Review

• Review and approve validation protocols and reports. 
• Review and approve product quality reviews. 
• Monitor stability and reserve sample programs.
• Ensure availability of stability data to support retest or expiry dates and storage conditions for APIs and intermediates, wherever applicable.

Audits, Inspections and Customer Interface

• Handle customer and regulatory inspections. 
• Carry out quality system audits and internal audits to verify compliance with GMP principles. 
• Perform vendor and service provider audits as required. 
• Handle customer queries and complaints related to quality matters.

Training and Capability Building

• Ensure Basic GMP, refresher GMP, updated GMP, and data integrity training are provided to all company employees. 
• Ensure recruitment of Quality Control and Quality Assurance department resources is completed as per business and site requirements.
• Build quality capability across site functions through effective governance, coaching, and compliance culture.

Cross-functional Collaboration

• Coordinate with Manufacturing, Engineering, R&D, Purchase, Marketing, and other functions as required to ensure quality and compliance expectations are met.
• Partner with site leadership and global quality teams to drive inspection readiness, quality performance, and regulatory compliance.
• Perform any other responsibilities assigned by the Head of Quality, TAPI Global.

Qualifications

• Master’s degree in Chemistry, Pharmacy, Pharmaceutical Sciences, Microbiology, Chemical Engineering, or a related science discipline.
• 18 to 25 years of relevant experience in Quality Assurance, Quality Control, Regulatory Compliance, or Site Quality leadership within API, pharmaceutical, or chemical manufacturing.
• Significant experience in handling regulatory inspections, customer audits, GMP compliance, validation, documentation, deviation management, OOS investigations, CAPA, risk assessment, and batch release.
• Prior experience in a senior site quality leadership role is preferred.
• Strong understanding of global regulatory expectations for APIs and intermediates.

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!