Global QA Director - Cell & Gene Therapy

Mix Talent; West Palm Beach (FL); On-site; USD 180,000 - 240,000; Full time

Job summary

Mix Talent seeks a Senior Director, Global Quality Assurance & CMC to lead the global Quality Management System across clinical‑stage cell and gene therapy programs. Based in West Palm Beach, this role reports to the Senior Director, Global QA & CMC and drives quality system execution, training oversight, and cross-site compliance.

You will oversee the design and implementation of a fit-for-purpose QC laboratory quality system, manage deviations, CAPA, change control, document control, audits,

Qualifications

• Bachelor’s degree in life sciences or related field.
• 7+ years of experience in Quality Assurance within biotech, pharmaceutical, or cell and gene therapy environments.
• Strong working knowledge of GMP, including FDA and international expectations.
• Hands-on experience with global quality systems (training, deviations, CAPA, change control, document control).

Responsibilities

• Support the implementation, maintenance, and continuous improvement of the global QMS in compliance with FDA, EMA, and ICH guidelines.
• Manage the global training program, including role-based training assignment and compliance tracking.
• Oversee QC laboratory quality system design, implementation, and maintenance for analytical testing activities.
• Support audits of internal and external partners and track CAPA commitments.
• Ensure data integrity and ALCOA+ compliance across quality and QC laboratory records.

Skills

QA leadership

GMP experience

Global QMS implementation

QC laboratory experience

Documentation & records

Cross-functional collaboration

Education

Bachelor’s degree in life sciences

Job description

Mix Talent seeks a Senior Director, Global Quality Assurance & CMC to lead the global Quality Management System across clinical‑stage cell and gene therapy programs. Based in West Palm Beach, this role reports to the Senior Director, Global QA & CMC and drives quality system execution, training oversight, and cross-site compliance.

You will oversee the design and implementation of a fit-for-purpose QC laboratory quality system, manage deviations, CAPA, change control, document control, audits,