Quality Product Complaints Associate Director

Vertex Inc.•Boston, MA

5d•Hybrid

About The Position

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.

Requirements

Demonstrated working knowledge and application of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) including US and international/global regulatory requirements and associated guidance's 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.

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