Senior QA Lead – Cell & Gene Therapy

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 96,000 - 110,000; Full time

Job summary

Vertex Pharmaceuticals LLC in Boston, MA is seeking a QA Manager (Contractor) to provide hands‑on QA oversight for analytical development and Quality Control within Cell and Genetic Therapy programs.

The role partners with Quality Control, Analytical Development, Manufacturing and MSAT to mitigate risks, resolve compliance issues, and support product development milestones while leading quality initiatives and building team capability.

Qualifications

• Bachelor’s degree in biotechnology, life sciences, engineering, or related field.
• Master’s degree or comparable relevant background preferred.
• 5+ years of experience in manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.

Responsibilities

• Provide QA oversight of analytical development and Quality Control activities, including method qualification, transfer, verification, and validation.
• Review and approve analytical lifecycle documents such as protocols, reports, and deviation investigations.
• Lead investigations and CAPA activities for quality events and OSI investigations.
• Ensure data verification and compliance review for deviations, root‑cause analyses, CAPA, and change controls.
• Maintain QA oversight of stability programs and regulatory standards across Vertex processes.
• Identify compliance risks and drive continuous improvement with stakeholders.
• Develop and maintain analytical quality standards, procedures, and training materials.
• Participate in cross‑functional Cell and Genetic Therapy projects and governance forums.
• Prepare and review regulatory submission sections as assigned.
• Support readiness for health‑authority inspections and information requests.
• Support contract testing laboratory management and Quality Agreements.
• Lead quality and technical improvement projects using RCA, data analytics, Lean, and Six Sigma.
• Mentor QA team and cross‑functional partners to foster a culture of Quality.

Skills

Quality Assurance

cGMP

Risk management

Regulatory knowledge

Leadership

Cross-functional collaboration

Root-cause analysis

Data analysis

Education

Bachelor’s degree in biotechnology, life sciences, engineering, or related field

Master’s degree or comparable background preferred

5+ years in biotechnology/pharma quality environment

Job description

Vertex Pharmaceuticals LLC in Boston, MA is seeking a QA Manager (Contractor) to provide hands‑on QA oversight for analytical development and Quality Control within Cell and Genetic Therapy programs.

The role partners with Quality Control, Analytical Development, Manufacturing and MSAT to mitigate risks, resolve compliance issues, and support product development milestones while leading quality initiatives and building team capability.