Senior Director, Analytical QA and Compliance

Vertex Inc.; Boston (MA); On-site; USD 157,000 - 235,000; Full time

Job summary

Vertex Inc. is seeking an Associate Director of Quality Assurance to oversee QC and analytical development activities, including release testing, stability, and investigations in cell & gene programs.

The role leads QA reviews of method validations and transfers, ensures GMP compliance, and supports regulatory submissions. This on-site position emphasizes data analytics, digital quality tools, and continuous improvement across program life cycles.

Qualifications

• Master's degree in a scientific or allied health field (or equivalent degree).
• Ph.D. preferred.
• 8+ years of experience in a regulated pharmaceutical environment.

Responsibilities

• Provide QA oversight of QC and analytical development activities.
• Lead QA review and approval of analytical development, qualification, validation, and transfer activities.
• Ensure stability program compliance with protocols and regulations.
• Review regulatory submissions and respond to regulatory questions.
• Lead RCA/CAPA for OOS/OOT results and investigations.
• Oversee QA for internal QC labs and external contract testing labs.
• Draft and enforce Quality Agreements with contract labs.

Skills

Quality Assurance

Regulatory Compliance

Root Cause Analysis

Analytical Method Transfer

LEAN / Six Sigma

Data Analytics

Communication

Leadership

Education

Master's degree in a scientific or allied health field

Ph.D. preferred

Tools

MES

LIMS

eQMS

Data visualization tools

Job description

Vertex Inc. is seeking an Associate Director of Quality Assurance to oversee QC and analytical development activities, including release testing, stability, and investigations in cell & gene programs.

The role leads QA reviews of method validations and transfers, ensures GMP compliance, and supports regulatory submissions. This on-site position emphasizes data analytics, digital quality tools, and continuous improvement across program life cycles.