Product Quality Complaints Specialist – Pharmaceutical QA

Product Quality Complaints Specialist – Pharmaceutical QA

Global Pharmaceutical Company | Quality Operations | Product Quality Complaints

We are partnering with a global pharmaceutical organisation seeking an experienced Product Quality Complaints Specialist to join its corporate Quality Operations function.

This is an opportunity to take ownership of product quality complaint management across an international pharmaceutical portfolio, working closely with manufacturing sites, external partners and global quality teams to ensure effective investigations, regulatory compliance and continuous improvement.

Key Responsibilities

• Manage the end-to-end product quality complaint process, including complaint registration, assessment, investigation coordination, reporting and closure.
• Coordinate with internal manufacturing sites and Contract Manufacturing Organisations (CMOs), reviewing investigation reports and ensuring appropriate corrective and preventive actions (CAPAs).
• Perform and support root cause investigations using structured problem-solving methodologies, including 5 Whys, Fishbone and FMEA.
• Maintain product complaints within the electronic Quality Management System (eQMS), ensuring accurate documentation, tracking and timely resolution.
• Assess quality risks, identify potential product quality defects and escalate significant issues appropriately.
• Collaborate with global affiliates, distributors, manufacturing partners and Pharmacovigilance teams, including monthly complaint reconciliation.
• Develop and maintain global SOPs, support quality system improvements and deliver relevant training.
• Monitor complaint trends, prepare quality KPIs and support initiatives to reduce recurring product quality issues.

Requirements

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Engineering or a related scientific discipline.
• 4+ years of experience within the pharmaceutical or biotechnology industry, ideally in Quality Assurance, Quality Operations or related functions.
• Strong understanding of GMP/GxP requirements, pharmaceutical quality systems and applicable regulatory standards.
• Experience in product quality complaints, investigations, root cause analysis and CAPA management would be highly relevant.
• Strong organisational, problem-solving and stakeholder management skills.
• Ability to work independently while collaborating with cross-functional and international teams.
• Fluent written and spoken English.

Desirable Experience

• Direct ownership of pharmaceutical product quality complaints.
• Experience collaborating with external manufacturing partners, CMOs or global affiliates.
• Working knowledge of electronic Quality Management Systems, including Ennov or similar platforms.
• Exposure to complaint trending, quality risk management, SOP development and process improvement.
• Additional language skills, particularly French.

The Opportunity

Join a global pharmaceutical Quality function with responsibility spanning product quality, manufacturing partners, regulatory compliance and continuous improvement.

The role offers the opportunity to work across an international organisation, contribute to global quality processes and play an important part in maintaining product quality standards throughout the pharmaceutical supply chain.

Interested? Apply to learn more about the opportunity.