Senior Operational Quality Assurance Specialist

Join Immatics and shape the future of cancer immunotherapy; one patient at a time!  

Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics. 

Why Join Us? 

• Innovative Environment: Help to pioneer advancements in cancer immunotherapy. 
• Collaborative Culture: Be part of a diverse team dedicated to your professional growth. 
• Global Impact: Contribute to therapies that make a lasting impact on patients globally. 

Role Overview 

We are seeking a Senior Operational Quality Assurance Specialist to support our Operational Quality Assurance & Systems team. This role is responsible for ensuring quality and compliance across manufacturing and CMC activities by conducting internal audits and supporting batch and material release processes. You will maintain and manage key documentation, including standard operating procedures, work instructions, lab records, and manufacturing data, while helping uphold high standards in a regulated environment.  

Schedule: 0700– 1530; Monday to Friday 

Reports to: Senior Operational Quality Assurance Manager  

Location: 13203 Murphy Road Suite 100 Stafford, TX 77477 

Basic Qualifications: 

• 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 

Preferred Qualifications:  

• Advanced degree (Master’s or higher) in pharmaceutical sciences, life sciences, bioengineering, or a related field  
• Experience in cell and gene therapy or advanced therapeutics within a GMP-regulated environment  
• Strong knowledge of global regulatory requirements (e.g., FDA, EMA, ICH) for biologics or advanced therapies  
• Advanced ability to interpret complex manufacturing and analytical data to support quality decisions 

In this role you will: 

• 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 regulatory guidelines and best practices  
• Support audits, inspections, and regulatory submissions, and provide guidance to junior QA team members 

What do we offer?  

At Immatics, we believe in investing in our team’s health, safety and well-being. Here’s what you can expect if you join Immatics 

Comprehensive Benefits:  

• Competitive rates for Health, Dental, and Vision Insurance 
• 4 weeks of vacation, granted up front each year and prorated for first and last year of employment. 
• 12 company paid holidays 
• 7 days of sick time 
• 100% employer-paid life insurance up to at 1x annual salary, up to one hundred thousand dollars  
• 100% employer-paid short- and long-Term disability