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

Vertex Inc.•Boston, MA

5d•$147,500 - $221,300•Hybrid

About The Position

The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness and compliance of external sites including evaluating, improving, and monitoring commercial level quality compliance and quality culture.

Requirements

Knowledge of regulatory requirements and inspection expectations globally
Strong technical knowledge including but not limited to: inspection management and risk management
Continuous improvement experience such as six sigma or lean
Proven ability to lead improvement projects and project teams and organize various teams and forums
Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams
Proven ability to identify and analyze performance indicators.
Bachelor's degree in a scientific discipline, or allied health field or equivalent degree
8+ years of relevant experience

Nice To Haves

Experience in multiple modalities preferred

Responsibilities

Responsible for inspection readiness and compliance programs for external operations.
Works cross-functionally and cross-company to ensure sites achieve and maintain a state of inspection readiness.
Drive identification and resolution of issues, gaps and risks through collaboration with operational areas, assessments, audits, and evaluation of trends.
Support and oversee inspection execution including responses and closure of CAPAs.
Serve as an integrator across multiple functions, fostering collaboration and knowledge sharing.
Develop trusted partnerships with external sites.
Drive optimization, continuous improvement, and operational excellence to enhance processes.
Report inspection readiness status including risks to leadership and governance forums.