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 operates with a high degree of autonomy and is expected to influence decision-making drive risk-based outcomes and contribute to the ongoing evolution of the Product Complaints quality system.

Key Duties and Responsibilities:

End-to-end ownership of complaints process

• Complaint handling accountability

• Identify new capabilities implementing/ delivering improvements

• Identify and implement automation & AI driven solutions to enhance efficiencies and compliance robustness

• Maintain inspection readiness as a steady state

• Lead and provide direction on complex and high-risk investigations

• Lead product complaint investigations coordinating with CMOs for external investigations performing Root Cause Analysis identifying Corrective Actions and escalating critical issues to senior management.

• Lead the product complaints trending programme including identification and investigation of adverse trends.

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

Signal detection and risk evaluation

• Proactively identify issues before they manifest as reportable events recurring trends or regulatory findings

• Development and application of risk threshold and triggers

Decision Authority and Escalation Leadership

• Understand where decision making boundaries lie

• Present risk balanced recommendations instead of data summaries

Cross Functional Influence & Integration

• Strengthen and maintain feedback loops into key partners - e.g. QA operations MSAT Device Engineering

Operational Excellence and Continuous Improvement

• Identify opportunities for reducing process complexity (cross-modality integration)

• Ownership and report out of QMR/ QLT data for responsible workstreams

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 devices/ combination products biologics cell and gene).

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.