Associate Director, Analytical QA for Cell & Gene

Vertex Pharmaceuticals Inc (US); Boston (MA); On-site; USD 156,600 - 234,800; Full time

Benefits offered by this job

Medical, dental, vision coverage

Generous PTO and shutdowns

Educational assistance

Commuting subsidy

401(k) with company match

Job summary

Vertex Pharmaceuticals Inc. is seeking an Associate Director of Quality Assurance to oversee QA across QC and analytical development for Cell & Gene programs.

The role drives QA oversight from method validation to transfer, stability testing, and regulatory submissions to ensure compliance with FDA/EMA and internal SOPs. The AD QA will act as SME for QC activities, lead CAPA, deviation, and change control processes, and leverage MES, LIMS, and eQMS to boost efficiency.

Qualifications

• Master’s degree in a scientific or allied health field; Ph.D. preferred.
• 8+ years of regulated pharmaceutical experience or equivalent mix of education and experience.
• In-depth knowledge of GxP QA and QC activities in cell therapies and GMP regulations.
• Experience with MES, LIMS, and eQMS systems and data analytics.
• Experience running internal analytical labs and collaborating with external test labs.
• Proficiency in analytical method development.
• Strong Root Cause Analysis, data analytics, and Lean Six Sigma frameworks.
• Excellent communication and problem-solving skills.

Responsibilities

• Act as QA SME for QC, leading QA review of development, qualification, and validation activities.
• Ensure stability programs comply with protocols and regulations.
• Review regulatory submission sections and assist in regulatory responses.
• Conduct RCA and manage CAPA for OOS/OOT results.
• Lead QA review of deviation investigations, OOS, OOT, and change controls.
• Provide QA oversight for internal and contract testing labs.
• Draft and enforce Quality Agreements with contract labs and Vertex.
• Leverage MES, LIMS, eQMS, and data analytics to improve quality oversight.
• Serve as SME during audits and inspections; support QA risk management.
• Support development of Vertex quality systems and SOPs.

Skills

Quality Assurance

GxP QA

Analytical method development

Data analytics

Regulatory submissions

Lean Six Sigma

Root Cause Analysis

Education

Master’s degree in science

Ph.D. preferred

Tools

MES

LIMS

eQMS

Data visualization

Job description

Vertex Pharmaceuticals Inc. is seeking an Associate Director of Quality Assurance to oversee QA across QC and analytical development for Cell & Gene programs.

The role drives QA oversight from method validation to transfer, stability testing, and regulatory submissions to ensure compliance with FDA/EMA and internal SOPs. The AD QA will act as SME for QC activities, lead CAPA, deviation, and change control processes, and leverage MES, LIMS, and eQMS to boost efficiency.