Overview
Role: Product Complaints Quality Manager
Company: Vertex Pharmaceuticals
Type of Role: Contract position, Inside IR35
Location: Hybrid, 3 days on site in Paddington, London, UK
Department: Operational Area Quality
Looking for opportunities with purpose, impact and possibilities? Our client, Vertex, is a global biotechnology company that invests in scientific innovation. As they grow their pipeline at pace, they are strengthening their reputation for creating transformative medicines for people with serious diseases.
Responsibilities
* Provide quality oversight of the Product Complaint Quality System and Global Recall and Defect Notification Systems.
* Support quality activities within the CMC Compliance team and partner with cross-functional teams including Global Patient Safety, Supply Chain/Trade and Distribution, Medical Information, Guidance and Patient Support, Quality Assurance, Contract Manufacturing Organizations and external Call Centers.
* Process product complaints (clinical and commercial), including intake, initial evaluation and triage; manage sample handling, triage, and SOP updates.
* Conduct product complaint investigations and author investigation reports; coordinate with CMOs for external investigations.
* Perform quality reviews of investigations owned by others; escalate critical issues to senior management.
* Oversee global recall and defect notification activities (mock recalls, SOP management, regulatory intelligence, system health).
* Lead product complaint investigations, perform Root Cause Analysis, identify Corrective Actions and escalate high-risk issues.
* Develop quarterly product complaint trend reports, initiate trend investigations and evaluate metrics/KPIs for quality impact and adverse trends.
* Coordinate Counterfeit/Suspect product investigations and evaluate third-party reports for potential threats or escalations.
* Contribute to quarterly Quality Management Review (QMR) meetings for Product Complaints and support global regulatory inspections and inspection readiness activities.
Qualifications / 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, analytical thinking and problem-solving skills.
* Strong technical writing, presentation and communication skills.
* Experience in Medical Devices and Combination Products is an advantage.
* Bachelor’s degree in a scientific or allied health field.
Note: Vertex is partnering with Talent Works to manage international temporary job openings. If selected, you will be employed by Talent Works to work on a temporary assignment at Vertex.
#J-18808-Ljbffr