Global Quality Auditor

Global Quality Auditor

Reports to: Global Head of Quality

The company:

The organisation, a global pharmaceutical company headquartered in Spain, operates worldwide in scientific research, manufacturing, and marketing of pharmaceutical products for human health. It comprises three divisions: Industrial, Branded, and Biotech, with 6000+ professionals in 40+ countries, 15+ facilities, 10+ R&D centers, and 10 commercial offices. They serve 1,150 customers in 96 countries, focusing on innovation, sustainability, and affordable access to quality medicines.

Role Overview:

The Global Quality Auditor reports to the Global Quality Audit Regional Team Leader. Their main responsibility is to conduct GxP Quality audits on a global scale.

Responsibilities:

• Supporting the development of a global risk-based audit strategy.
• Planning, conducting, and documenting GMP audits worldwide in line with quality procedures and regulations.
• Handling complex audits, including sterile API, aseptic DP, and combination products, by assessing risks effectively.
• Providing technical guidance, mentoring, and training on audit activities.
• Offering regulatory advice for remediation and filing recommendations.
• Preparing audit reports, ensuring timely communication with audit sites.
• Escalating critical findings and supporting follow-up actions.
• Reviewing responses to audit findings and ensuring compliance with procedures.
• Acting as a GMP compliance consultant for various projects.
• Monitoring qualification activities and staying updated on regulations.
• Identifying best practices and contributing to auditor development.
• Reporting relevant metrics as requested.

Qualifications:

• Advanced degree in Chemistry, Pharmacy, Chemical Engineering, or related field.
• Excellent English communication skills, and Spanish proficiency is a plus.
• Minimum of 4 years' experience in GMP-regulated organizations.
• Strong understanding of EU and FDA regulations for pharmaceutical R&D, manufacturing, and distribution.
• Willingness to travel to upwards of 60%
• Objectivity and consistency in audits, effective communication skills, personal integrity.

Email applicants please forward to; jake.tookey@discoverinternational.com. With a copy of your CV and your availability for an initial screening call.