Product Quality Specialist – Global Pharma

About the role

The Product Quality Specialist provides oversight of product quality throughout new product development, from ideation to regulatory approval across global markets. Reporting to the Senior Director of Clinical Operations, the role ensures GMP and GDP compliance across the supply chain.

Key responsibilities

• Lead continuous improvement initiatives for product quality internally.
• Develop, review, and approve quality documentation such as batch manufacturing records, analytical methods, and quality records for new product submissions.
• Support external manufacturers with validation and stability protocols and generate Quality Technical Agreements for outsourced activities.
• Issue and manage annual internal and external audit schedules.
• Investigate product deviations, out‑of‑specifications, and prepare corrective and preventive actions (CAPAs).
• Assist with periodic regulatory reporting, vendor assessments, and audits.
• Approve documentation in the eQMS system and manage change controls, investigations, and risk assessments.
• Support rollout of quality training on site.

Required profile

• Bachelor’s degree in Quality, GMP, Pharmaceutical Technology, or a related science discipline.
• Minimum 5 years of experience in a pharmaceutical quality environment.
• Project management experience is an advantage.

Required skills

• Good Manufacturing Practice (GMP)
• Good Distribution Practice (GDP)
• Electronic Quality Management System (eQMS)