Product Complaints Quality Manager (Ireland)
12 months contract. Company Name: Vertex Pharmaceuticals. Location: Hybrid, 3 days on site in Dublin, Ireland. Department: Operational Area Quality.
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases.
The Quality Product Complaints Manager is responsible for providing quality oversight of the Product Complaint Quality System and Global Recall and Defect Notification Systems, supporting activities associated within the CMC Compliance team and partnering with various internal and external cross‑functional teams.
Key Duties and Responsibilities
* Support activities associated with the product complaint process, including reconciliation, training, complaint sample management, triage, trending, SOP management, etc.
* Process incoming clinical and commercial product complaints, including intake, initial evaluation and triage.
* Conduct product complaint investigations and author investigation reports.
* Coordinate with CMOs as needed for external investigations.
* Perform Quality review of complaint investigations owned/authored by other members of the team.
* Escalate critical issues to senior management.
* Oversee all activities associated with the global recall and defect notification processes, including mock recalls, SOP management, evaluation of regulatory intelligence and health of the systems.
* Lead product complaint investigations, coordinate with CMOs for external investigations, perform Root Cause Analysis, identify Corrective Actions and escalated critical issues to senior management.
* Develop quarterly product complaint trend reports, initiate trend investigations and evaluate metrics/KPIs to assess quality impact and adverse trends.
* Coordinate activities associated with Counterfeit/Suspect product investigations and evaluate third‑party investigation reports for potential threats / required escalation.
* Contribute to quarterly Quality Management Review (QMR) meetings for Product Complaints.
* Support global regulatory inspections and inspection readiness activities.
Knowledge and Skills
* Strong understanding of industry standards and best practices.
* Proven ability to collaborate with cross‑functional teams.
* Proven ability to manage projects of significant scope and complexity, while meeting deliverables and timelines.
* Strong strategic, critical and analytical thinking skills.
* Strong technical writing, presentation and communication skills.
* Experience in Medical Devices and Combination Products an advantage.
* Bachelor’s degree in a scientific or allied health field.
Vertex is partnering with Talent Works to manage their international temporary job openings. If you are successful in your application, you will be employed by Talent Works to work on a temporary assignment at Vertex.
Seniority level: Mid‑Senior level. Employment type: Contract. Job function: Quality Assurance. Industries: Pharmaceutical Manufacturing, Medical Equipment Manufacturing, Biotechnology Research.
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