Quality Product Complaints Associate Director

General Summary:

The Quality Product Complaints Associate Director is responsible and accountable for providing quality oversight of the Product Complaint Quality System and the Global Recall and Defect Notification Systems. This role will support quality activities associated within the 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. The Associate Director also drives continuous improvement in Vertex quality processes and governance to assure Vertex remains adherent to regulatory expectations and supports QA operational quality oversight and management of complex issues. The role requires strong leadership people management skills and the ability to lead high performing and effective teams.

Key Duties and Responsibilities:

• Responsible for activities associated with the product complaint process including reconciliation training complaint sample management triage trending and SOP management etc.

• Supports activities associated with the global recall and defect notification processes including mock recalls SOP management evaluation of regulatory intelligence and health of the systems.

• Manages Suspect Product and Counterfeit investigations and oversees the corresponding processes.

• Processes incoming clinical and commercial product complaints including intake initial evaluation and triage

• Leads product complaint investigations coordinates with CMOs for external investigations performs Root Cause Analysis identifies Corrective Actions and escalates critical issues to senior management

• Works closely with Vendor Management and Inspection Readiness teams on vendor related investigations and contributes to vendor score carding for applicable CMOs

• Develops quarterly product complaint trend reports and oversees trending program; initiates trend investigations and evaluates metrics/KPIs to assess quality impact and adverse trends

• Compiles data and drafts applicable sections of the Annual Product Review (APR)

• Develops content for quarterly Quality Management Review (QMR) for Product Complaints

• Provides training to cross functional teams on the product complaint process and supports training and knowledge management regarding the recall and defect notification processes

• Supports global regulatory inspections and inspection readiness activities

• Supports quality activities including deviation and SOP review QA to GPS business meetings for activities associated with AE/PC reporting and other activities as needed

• Participates in Regulatory Surveillance activities as an SME and evaluates new regulatory intelligence to update processes/procedures as necessary

• Responsible for gap assessments related to changes in regulations Vertex Standards and new modalities (as applicable)

• Responsible for system health on-time complaint closure and adherence to expectations for the high performing complaint and recall quality systems

Knowledge and Skills:

• Demonstrated working knowledge and application of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) including US and international/global regulatory requirements and associated guidances and standards across multiple modalities (e.g. small molecule device biologics).

• Strong working knowledge and experience in:

• Product Complaints Recalls Field Alerts and Defect Notifications to Health Authorities

• Risk Management

• Event/Quality Issue Management process and requirements including CAPA and Effectiveness Checks;

• Root Cause Analysis and Investigation process tools and techniques;

• Inspection Readiness

• Strong oral and written communication and interpersonal skills

• Project Management Planning and Prioritization skills

• Technical writing skills

• Adaptability / flexibility and ability to work in a fast-paced environment and act with urgency

• Strategic big picture thinking while maintaining ability to execute at a tactical level / attention to detail.

• Strong analytical thinking skills with the ability to translate data into risk-informed insights that drive decision-making.

• Experience advising coaching and mentoring junior staff as well as leading high performing and effective teams

Education and Experience:

• Masters degree or bachelors degree in a scientific or allied health field (or equivalent degree)

• 5-8 years of relevant work experience (with Masters Degree) or 10 years of relevant working experience (Bachelors degree or relevant comparable background.

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