About the job

Lead Investigator, Quality InvestigationsSite-Based | Open to EU Passport Holders

Are you passionate about solving complex quality issues, identifying root causes, and driving meaningful improvements within a GMP-regulated environment?

We're partnering with a rapidly growing global biopharmaceutical organization that develops and commercializes complex medicines for international markets. The business has established itself as a recognized leader in product development, manufacturing excellence, and global healthcare partnerships, offering employees the opportunity to work in a highly collaborative, science-driven environment.

As part of continued growth, we're seeking a Lead Investigator to join the Quality organization and play a key role in managing Product Quality Complaint investigations and other critical quality events.

The OpportunityYou will lead complex investigations from initiation through closure, ensuring quality events are thoroughly assessed, root causes are identified, and robust CAPAs are implemented.

This role offers significant cross-functional exposure, partnering closely with Manufacturing, Quality Control, Engineering, Supply Chain, and external partners to ensure the highest standards of product quality and patient safety.

• Key ResponsibilitiesLead and manage Product Quality Complaint (PQC) investigations from initiation through closure
• Conduct scientifically sound root cause analyses using structured investigation methodologies
• Assess product impact and support quality risk evaluations
• Develop, implement, and monitor corrective and preventive actions (CAPAs)
• Collaborate with Manufacturing, QC, Engineering, Supply Chain, and other stakeholders to drive investigation outcomes
• Ensure investigations are completed in line with GMP requirements, internal procedures, and agreed timelines
• Support deviation, OOS, and other quality event investigations as required
• Identify opportunities to strengthen investigation processes and improve the Quality Management System

• What We're Looking ForDegree in Chemistry, Microbiology, Pharmacy, Biochemistry, Engineering, or a related scientific discipline
• Minimum 3 years of investigation experience within a GMP pharmaceutical or biotechnology environment
• Proven experience leading Product Quality Complaint, deviation, OOS, and CAPA investigations
• Strong understanding of cGMP requirements and pharmaceutical quality systems
• Experience with root cause analysis and risk assessment methodologies
• Excellent analytical, problem-solving, and technical writing skills
• Ability to manage multiple priorities and work effectively across cross-functional teams
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