GCP Operational Quality Director

Vertex Inc.; Boston (MA); Hybrid; USD 218,000 - 326,000; Full time

Job summary

Vertex Inc. seeks a Sr. Director, GCP Operational Quality to provide strategic direction for risk management and inspection readiness across clinical programs. The role leads QA governance, integrates quality principles, and partners with stakeholders to optimize operational performance.

Responsibilities include shaping risk-based quality management, advancing Quality by Design, and guiding cross-functional teams toward proactive quality outcomes and inspection readiness across GXP functions.

Qualifications

• Proven experience in applying risk-based quality principles (e.g. QbD) in a pharmaceutical environment.
• Strong leadership capabilities within multi-level organizations.
• Experience with program and enterprise risk management, RCA and Lean/Six Sigma.
• Strategic planning and execution skills for quality oversight across development programs.

Responsibilities

• Provide strategic direction and oversight to quality risk management and inspection readiness across program areas.
• Design and partner on Quality strategy with stakeholders for real-time inspection readiness.
• Lead risk-based quality management and ensure effectiveness of monitoring and mitigation mechanisms.
• Oversee development and maintenance of quality plans summarizing quality activity results.
• Lead quality working groups to deliver integrated plans across QA functions.
• Advise business partners on proactive quality approaches and new models/technologies.

Skills

Quality risk management

GCP

Strategic leadership

Communication

Analytical thinking

Project management

Quality by Design

Education

M.S. (or equivalent degree) and 10+ years of relevant work experience

B.S. in a scientific or allied health field (or equivalent degree) and 15+ years of relevant work experience

Job description

Vertex Inc. seeks a Sr. Director, GCP Operational Quality to provide strategic direction for risk management and inspection readiness across clinical programs. The role leads QA governance, integrates quality principles, and partners with stakeholders to optimize operational performance.

Responsibilities include shaping risk-based quality management, advancing Quality by Design, and guiding cross-functional teams toward proactive quality outcomes and inspection readiness across GXP functions.