Position Summary
The Global Manager, Customer Complaints is responsible for the global oversight, execution, and continuous improvement of the pharmaceutical complaint management program. This role leads a team of complaint investigators and ensures all product quality complaints are properly triaged, investigated, documented, and closed in compliance with international regulations and internal quality standards.
The position serves as a subject-matter expert in complaint handling, partnering with Manufacturing, Quality Control, Supply Chain, Regulatory Affairs, and Pharmacovigilance to drive high-quality investigations, identify root causes, implement CAPAs, and reduce product issues globally.
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Key Responsibilities
Complaint Management & Oversight
- Lead the end-to-end global complaint process including intake, triage, assignment, investigation, documentation, and closure.
- Assign complaints to investigators based on expertise, workload, product knowledge, and investigation complexity.
- Ensure complaints are processed in compliance with FDA, EMA, MHRA, Health Canada, WHO, and other relevant regulations.
- Review and approve complaint investigations, interim assessments, and final reports for technical accuracy, regulatory compliance, and completeness.
- Establish and track performance metrics for complaint processing (e.g., on-time closure, investigation quality, backlog reduction).
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Management of Complaint Investigators
- Directly lead and develop a team of complaint investigators (onsite, remote, or global).
- Provide coaching, technical guidance, and escalation support on complex investigations and root-cause analysis.
- Conduct routine 1:1s, performance reviews, and competency assessments for complaint investigators.
- Ensure investigators are trained on applicable SOPs, regulatory expectations, and investigation tools/methodologies.
- Monitor workload distribution and adjust assignments to ensure timely complaint closure and balanced productivity.
- Conduct periodic quality reviews of investigator work, identifying areas for improvement and coordinating retraining when necessary.
- Develop and maintain a culture of scientific rigor, accountability, and continuous improvement among the investigation team.
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Cross-Functional Collaboration
- Partner with Manufacturing, QC, Engineering, Supply Chain, and other functions to ensure timely and effective investigations.
- Collaborate with global affiliates to ensure consistent complaint intake, escalation, and documentation.
- Work closely with Pharmacovigilance for medical complaint alignment and AE reporting.
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Regulatory Compliance & Inspection Readiness
- Serve as the subject-matter expert (SME) for global complaint handling during regulatory inspections and audits.
- Ensure all investigators are inspection-ready and capable of articulating investigation rationale and methodology.
- Lead or support development of responses to regulatory findings related to complaint handling.
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CAPA & Continuous Improvement
- Ensure CAPAs linked to complaint investigations are clearly defined, risk-based, implemented on time, and verified for effectiveness.
- Review complaint trends, perform periodic quality metrics reporting, and identify recurring issues.
- Lead global initiatives to improve investigation quality, complaint handling efficiency, and system performance.
- Drive harmonization and standardization of complaint investigation procedures across global sites.
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Systems Management
- Serve as business owner or key user for the global complaint management system (e.g., TrackWise, Veeva QMS, EtQ).
- Ensure investigators properly utilize QMS workflows and maintain high data integrity standards.
- Partner with IT/TechOps on system enhancements and validations.
Education
- Bachelor’s degree in Life Sciences, Pharmacy, Engineering, Chemistry, or related field required.
- Advanced degree (MS, MBA, PharmD) preferred.
Experience
- 7–10 years of experience in pharmaceutical or biotech quality systems.
- Minimum 3 years directly managing complaint handling, quality investigations, or QA operations.
- Experience managing, training, or mentoring investigators strongly preferred.
- Experience supporting regulatory inspections (FDA, EMA, MHRA, etc.).
Skills & Competencies
- Deep understanding of GMP/GDP regulations.
- Strong analytical and root-cause analysis skills (5 Whys, Fishbone, DMAIC, FMEA).
- Excellent leadership, communication, and coaching abilities.
- Strong organizational skills with experience managing workload prioritization.
- Proficiency with electronic QMS platforms.
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Key Performance Indicators (KPIs)
- On-time complaint closure rate.
- Quality of investigations and recurrence reduction.
- Investigator performance and capability development.
- CAPA effectiveness rate.
- Accuracy and timeliness of trend reporting.
- Regulatory inspection outcomes related to complaints.
