Site Quality Head

Job Purpose:

The Site Quality Head (SQH) is responsible for the design, implementation, and continuous improvement of the site’s Quality Management System (QMS), fully aligned with TAPI’s global quality standards and international regulatory requirements. The SQH leads all Quality functions at the site—including Quality Assurance (QA), Quality Control (QC), and Quality Systems (QS)—and manages a team of approximately 130 FTE. This role reports directly to the Global Head of Quality, with a dotted‑line to the Site General Manager, ensuring strong alignment between global quality strategy and site operations. The SQH serves as the site’s senior quality authority, driving a strong quality culture, ensuring regulatory compliance, and overseeing all quality‑related processes, decisions, and governance to support operational excellence.
 

Responsibilities

Quality Leadership & Compliance

Lead the site’s Quality organization in establishing, maintaining, and continuously improving quality performance in alignment with TAPI’s global standards, regulatory expectations, and cGxP requirements. Ensure robust quality systems that minimize risk to products, processes, and patients. Oversight includes validation, change management, regulatory inspections, training and certification, investigations, batch release, quality systems approval, computerized systems, documentation, and overall compliance.

Team & Resource Management

Build, develop, and retain a high‑performing Quality team capable of executing quality processes with excellence. Ensure effective organizational structure, optimal resource allocation, and responsible management of the Quality budget to support site and corporate objectives.

Quality Culture & Engagement

Champion a strong, sustainable culture of quality across the entire site. As a key member of the site leadership team, promote behaviors, mindsets, and decision‑making that prioritize quality, compliance, and continuous improvement at all levels of the organization.

Implementation of Quality Strategy

Translate TAPI’s global quality strategy into actionable plans for the site. Identify systemic issues requiring holistic solutions and lead cross‑functional initiatives to implement improvements while ensuring full compliance with evolving regulatory requirements.

Policies & Procedures Governance

Define, approve, and maintain site-level quality policies and procedures in alignment with global standards. Ensure clarity, consistency, and effective implementation across all operational areas.

Quality Planning & Execution

Develop annual and long‑term work plans for the Quality department that support Teva’s global quality strategy and the site’s operational goals. Monitor execution and adjust priorities as needed.

Quality Systems & Documentation

Ensure the establishment, maintenance, and continuous improvement of an up‑to‑date, compliant, and effective set of procedures and quality systems that meet global, corporate, and regulatory requirements.

Quality Integration in Site Leadership

Embed quality considerations into site leadership decision‑making. Ensure the site meets quality KPIs and proactively escalate critical issues. Lead or oversee major investigations, ensuring timely, thorough, and compliant resolution.

Collaboration Across Quality Network

Actively collaborate with TAPI’s global Quality leadership. Share best practices, challenges, and lessons learned to strengthen global quality performance and harmonization across sites.

Audit & Inspection Readiness

Ensure all site units maintain a constant state of readiness for internal and external audits. Lead preparation activities and support teams during inspections to ensure successful outcomes.

Regulatory Agency Engagement

Develop and maintain constructive, transparent, and proactive relationships with regulatory authorities. Represent the site during inspections and ensure timely, accurate communication and follow‑up.

Independent Quality Authority

Serve as the site’s independent authority on quality and compliance matters. Exercise the right and responsibility to halt operations, reject materials, or escalate issues when quality or patient safety may be at risk.

Candidate Qualifications

Education

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field (e.g., Chemistry, Biotechnology, Pharmaceutical Chemistry, Pharmacy).

Experience

• 10+ years of managerial experience within a pharmaceutical or API manufacturing environment, including at least 5 years in Quality and/or Compliance roles with strong exposure to site operations.
• Demonstrated experience interacting with Health Authorities and managing compliance activities, including audits, inspections, response writing, and CAPA management.

Technical Expertise

• Advanced knowledge of local GxP requirements and international regulatory expectations, including those of the US FDA and EMA.
• Strong understanding of quality systems, operational processes, and regulatory compliance within a manufacturing setting.
• Strong understanding and knowledge of QC.

Leadership & Interpersonal Skills

• Excellent communication, negotiation, and presentation skills, with the ability to influence and collaborate effectively across all organizational levels.
• Proven ability to lead teams, work cross‑functionally, and operate effectively in complex, matrixed environments.
• High level of intercultural awareness and the ability to work effectively in a global context.

Personal Attributes

• Energetic, committed, and driven by continuous improvement and evolving compliance expectations.
• Proactive, self‑motivated, flexible, and able to think innovatively when solving problems.
• Strong sense of accountability and professional integrity.