Senior Operational Quality Assurance Specialist - Cell & Gene Therapy

3d3 days ago

Immatics

Houston, US · Full-time · $105,000 – $135,000

About this role

Immatics is seeking a Senior Operational Quality Assurance Specialist to join our Operational Quality Assurance & Systems team in Houston, TX. In this role, you will be responsible for ensuring quality and compliance across manufacturing and CMC activities by conducting internal audits and supporting batch and material release processes. You will help uphold high standards in a regulated environment as we pioneer advancements in cancer immunotherapy.

Day to day, you will oversee batch release activities for cell and gene therapy products, ensuring compliance with regulatory requirements and company standards. You will review and approve batch records, analytical data, and documentation for accuracy and completeness, while performing quality checks to verify product identity, potency, purity, and safety attributes.

You will collaborate cross-functionally to resolve quality issues, deviations, and non-conformances, driving CAPA implementation and supporting continuous improvement of batch release processes. The role reports to the Senior Operational Quality Assurance Manager and follows a 7:00 AM – 3:30 PM schedule, Monday to Friday.

This position offers the opportunity to contribute to therapies that make a lasting impact on patients globally while working in an innovative environment that supports professional growth. You will be part of a diverse team dedicated to making a meaningful impact on the lives of patients with cancer.

Requirements

Bachelor’s degree in pharmaceutical sciences, life sciences, bioengineering, or a related field
4+ years of experience in quality assurance within biotechnology or pharmaceutical environments, including batch release activities
4+ years of experience working in regulated environments with cGMP and GCP standards
Demonstrated experience reviewing batch records, analytical data, and technical documentation for product release
Proven experience managing deviations, investigations, and CAPA processes
Advanced degree (Master’s or higher) in pharmaceutical sciences, life sciences, bioengineering, or a related field (preferred)
Experience in cell and gene therapy or advanced therapeutics within a GMP-regulated environment (preferred)
Strong knowledge of global regulatory requirements (e.g., FDA, EMA, ICH) for biologics or advanced therapies (preferred)

Responsibilities

Oversee batch release activities for cell and gene therapy products, ensuring compliance with regulatory requirements and company standards
Review and approve batch records, analytical data, and documentation for accuracy, completeness, and compliance
Perform quality checks to verify product identity, potency, purity, and safety attributes
Collaborate cross-functionally to resolve quality issues, deviations, and non-conformances
Drive CAPA implementation and support continuous improvement of batch release processes
Maintain and update procedures and documentation in line with current regulatory requirements
Conduct internal audits to ensure quality and compliance across manufacturing and CMC activities
Support material release processes and manage key documentation including SOPs, work instructions, lab records, and manufacturing data

Benefits

Innovative environment helping to pioneer advancements in cancer immunotherapy
Collaborative culture with a diverse team dedicated to professional growth
Opportunity to contribute to therapies that make a lasting impact on patients globally
Cutting-edge science and robust clinical pipeline in the broadest PRAME franchise