Global Analytical Method Lead - GMP & Compliance

PE Global; Dublin; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

PE Global is recruiting an Associate Scientist for a North Dublin client on a 12-month initial contract with hybrid work. The role focuses on method transfers, validations, and change controls within GMP Quality Control, partnering with internal teams and CMOs.

Reporting to a Principal Scientist, you will manage external lab testing, QA agreements, and knowledge management across commercial analytical. The position requires a degree in biological sciences or chemistry and at least five years in

Qualifications

• Bachelor’s degree in Biological Sciences, Chemistry or related discipline.
• Minimum 5 years’ experience in Quality and Compliance.
• Knowledge of the commercial analytical method lifecycle.
• Experience with analytical change controls in a GMP environment.
• Excellent communication and interpersonal skills.

Responsibilities

• Own and/or support analytical method transfers and validations in GMP QC labs, internally and externally – including protocols, reports and acceptance criteria, coordination, project updates.
• Own and/or support analytical change controls for changes to global test methods or regulatory filings.
• Own and/or support relationships with external organizations for analytical testing supporting manufacture and release of commercial products.
• Provide oversight of external lab testing systems and documentation, and of Quality Agreements and change controls, to ensure compliance with requirements and regulatory filings.
• Lead and manage projects with a global mindset to direct and influence multiple remote teams.
• Emb o dy a compliance, quality and continuous improvement mindset; convey urgency and drive issues to closure.
• Create and maintain an environment where employees are engaged, speak up, and develop.

Skills

Analytical thinking

Communication skills

Cross-functional collaboration

Quality systems

GMP knowledge

Education

Bachelor’s degree in Biological Sciences/ Chemistry

MS/PhD preferred

Job description

PE Global is recruiting an Associate Scientist for a North Dublin client on a 12-month initial contract with hybrid work. The role focuses on method transfers, validations, and change controls within GMP Quality Control, partnering with internal teams and CMOs.

Reporting to a Principal Scientist, you will manage external lab testing, QA agreements, and knowledge management across commercial analytical. The position requires a degree in biological sciences or chemistry and at least five years in