Global Quality Director – Senior Leadership Role

About the role

The Global Quality Director is a senior corporate leader responsible for defining, governing, and embedding a unified global quality framework across all operational sites. Reporting to C‑Level executives, the role safeguards patient safety, regulatory compliance, and corporate reputation while supporting international expansion in highly regulated environments such as pharmaceuticals and regulated consumer products.

Key responsibilities

• Define and govern the Global Quality Regulatory Framework, issuing and updating corporate master policies on Data Integrity, Stability, Process Validation, and Risk Management.
• Harmonize technical criteria and quality decision‑making across multiple countries, sites, and business units.
• Lead regional and global quality organizations, ensuring inspection readiness and alignment with FDA, EMA/EU GMP, TGA, and other international standards.
• Drive corporate quality governance, regulatory intelligence, CAPA management, Data Integrity programs, and Quality Culture transformation initiatives.
• Act as the technical authority in regulatory inspections, certification processes, and high‑surveillance audits.

Required profile

• Fluent English (B2+/C1) and at least 9 years of experience in corporate, global, or regional quality leadership within multinational organizations.
• Degree in Chemistry or Pharmacy with a specialization or Master’s in Production Processes, Quality, Administration, Regulatory Affairs, or related fields.
• Extensive experience interacting with global regulatory bodies such as FDA, EMA/EU GMP, TGA, ANVISA, INVIMA, COFEPRIS, WHO, and PIC/S.
• Proven track record leading multicultural quality teams across multiple manufacturing sites.
• Strong executive presence and ability to influence C‑Level leadership and board committees.

Required skills

• GMP/cGMP compliance
• Regulatory compliance (FDA, EMA/EU GMP, TGA, etc.)
• Data Integrity
• Process Validation
• Risk Management
• CAPA management
• Quality governance and audit readiness