Associate Director, CMC Quality Compliance and Inspection Readiness (Hybrid)

$147.5k - $221.3k

Vertex Pharmaceuticals

Vertex Pharmaceuticals seeks an Associate Director to lead inspection readiness and compliance programs for external manufacturing sites. The role involves cross-functional collaboration to evaluate quality compliance, drive continuous improvement, and ensure regulatory readiness through audits, assessments, and CAPA management.

Responsibilities

Oversee inspection readiness and compliance programs for external manufacturing operations
Identify, analyze, and resolve quality gaps and risks through assessments and audits
Support inspection execution and lead CAPA responses and closure
Foster cross-functional collaboration and build partnerships with external sites
Report inspection readiness status and risks to leadership and governance

Requirements

Bachelor's degree in scientific discipline or allied health field
8+ years of relevant CMC quality or compliance experience
Knowledge of global regulatory requirements and inspection expectations
Technical expertise in inspection management and risk management
Experience with continuous improvement methodologies such as Lean or Six Sigma
Strong facilitation, communication, and team leadership skills
Ability to identify and analyze performance indicators and trends

Compensation: $147,500 - $221,300 base

Apply

Vacancy posted 5 days ago

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