Role:
Product Complaints Quality Manager
Company Name:
Vertex Pharmaceuticals
Type of Role:
Contract position, Inside IR35
Contract Length:
12 months
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.
General Summary:
The Quality Product Complaints Manager is responsible for providing quality oversight of the Product Complaint Quality System and Global Recall and Defect Notification Systems.
This role will support quality activities associated within the CMC Compliance team and will partner with various internal and external 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.
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.
* Oversees 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.
* Leads product complaint investigations, coordinates with CMOs for external investigations, performs Root Cause Analysis, identifies Corrective Actions and escalates critical issues to senior management.
* Develops quarterly product complaint trend reports, initiates trend investigations and evaluates metrics/KPIs to assess quality impact and adverse trends.
* Coordinates activities associated with Counterfeit/Suspect product investigations and evaluates third-party investigation reports for potential threats / required escalation.
* Contributes to quarterly Quality Management Review (QMR) meetings for Product Complaints.
* Supports 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.