Complaint Investigation Manager

Sourcing Recruiter | Randstad Sourceright MSP | A Randstad Enterprise Business | Temporary, Contract & MSP Specialist

Location: Hybrid working (UK, Switzerland, Belgium, Netherlands, or Ireland only).

Duration: 12 months

Hours: 40 hours

Imagine your next role supporting a global healthcare leader by ensuring the highest standards of product quality and safety, leading complex investigations that directly impact patient well-being and regulatory compliance.

To provide expertise and timely proactive support for the investigation, documentation, and resolution of Product & Signal Complaint Investigations, Nonconformances, and CAPAs. Reporting to the Director of PQM Strategy Deployment & Excellence, you will act as a Subject Matter Expert (SME) to drive end‑to‑end accountability and root cause excellence.

• Process Leadership:
  Acting as the SME for complaint investigation processes, providing guidance on technical and quality compliance within the PQM Team.
• Investigation Management:
  Ensuring deviations and complaints are investigated thoroughly and timely to meet internal and external customer expectations.
• Root Cause Analysis (RCA):
  Leading the application of structured problem‑solving methodologies (Fishbone, 5 Whys, etc.) for all Product & Signal investigations.
• Cross‐Functional
  
  Collaboration:
  
  Working directly with Device Engineers and PQI/PQO teams to ensure deep product knowledge of Synthetics, Proteins, and Cell/Gene therapies is integrated into investigations.
• Compliance Monitoring:
  Running reports to monitor Nonconformance and CAPA deliverables, communicating deadlines to owners, and escalating concerns to management to drive compliance.
• System Proficiency:
  Developing and maintaining expert‑level proficiency in COMET and associated quality systems.
• Stakeholder Engagement:
  Identifying organizational resources to support RCA investigations and resulting actions while fostering a culture of critical thinking.
• Governance:
  Escalating issues to the PQM CAPA Review Board and attending meetings as a representative for functional area investigations.

• Regulatory Knowledge:
  Maintain up‑to‑date, in‑depth understanding of relevant pharmaceutical legislation and cGMP regulations (Eudralex, ICH, Ph.Eur., USP, etc.) at global and regional levels.
• Safety Reporting:
  Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs are met and appropriately managed.
• Inspection Readiness:
  Ensure inspection readiness with respect to personal training compliance and availability of recent CV and individualized Job Description.
• Risk Management:
  
  Apply appropriate risk assessment strategies to manage business and compliance priorities and translate them into actionable plans.

• Internal Partnerships:
  Managing effective relationships with all key stakeholders including Patient Access, Communications, Finance, Commercial, and Medical teams.
• Global Engagement:
  Driving engagement with relevant EMEA stakeholders to ensure alignment on investigation standards.
• Conflict Resolution:
  Utilising negotiation skills to create win‑win situations with internal and external partners.

• Independent management of investigation timelines and prioritization of deliverables based on business needs.
• Authority to lead RCA methodologies and determine the adequacy of root cause documentation before closure.

We are looking for candidates with a BA/BS in Science or Engineering (Master’s preferred) and a minimum of 7 years of Pharmaceutical Industry experience.

• GXP Expertise: 3‑4 years of experience within Clinical R&D and/or Quality Assurance.
• Analytical Rigor:
  Strong critical thinking, leadership skills, and structured problem‑solving expertise.
• Communication:
  Excellent verbal and written skills to negotiate and communicate with customers and partners.
• Operational
  
  Skills:
  
  High commitment to quality, excellent time management, and the ability to work in a dynamic, changing environment.
• Software
  
  Skills:
  
  Proficient in Microsoft Office applications and familiar with corporate quality…