Complaint Quality Approver
$72,500–$72,500 year
On-siteLatina, Lazio, Italy or Beerse, Flanders, Belgium
Job Summary
Conduct independent quality review and grant final approval of complaint records to ensure investigations are complete, scientifically justified, and compliant with applicable regulations. Verify that investigation strategies, root cause analyses, and associated methodologies are robust, evidence-based, and involve necessary stakeholders, including supply chain impacts. Review investigation progress, address gaps, and ensure accurate documentation of new information, risks, and required actions before record closure. Coach investigation owners on CAPA best practices, system usage, and investigation quality while validating data integrity and confirming all nonconformances are assigned and tracked.
Required Qualifications
- Bachelor's degree in Life Science or related discipline (or equivalent experience)
- Minimum of 2-4 years of experience performing and/or reviewing quality investigations (complaints, deviations, nonconformances, or similar quality events)
- Experience working within quality systems and with applicable regulatory and compliance requirements
- Demonstrated ability to write clear, concise documentation and provide professional, actionable feedback
- Proven critical thinking, problem-solving, and decision-making skills
- Strong organization, prioritization, and time management skills
- Knowledge of complaint handling, investigations, and corrective and preventive action concepts in a regulated environment
- Understanding of cGMP, Good Documentation Practices, and applicable regulations; familiarity with U.S. and international GMP expectations for pharmaceuticals/medical products (as applicable to the site)
- Strong ability to review technical data and documents (e.g., batch records, test results, protocols, procedures) and identify gaps or inconsistencies
- Clear written communication skills to provide precise approval rationale and actionable feedback
- Analytical skills, including ability to interpret trends and performance metrics
- Ability to work independently and in teams
- Must be able to effectively operate in a matrixed environment and interact with cross functional local and global leaders on a regular basis
- Must be able to lift 50 lbs
Desired Qualifications
- Business Alignment
- Business Savvy
- Coaching
- Communication
- Compliance Management
- Continuous Improvement
- Fact-Based Decision Making
- Human-Centered Design
- ISO 9001
- Issue Escalation
- Problem Solving
- Quality Control (QC)
- Quality Management Systems (QMS)
- Quality Standards
- Regulatory Environment
- Standard Operating Procedure (SOP)
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