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
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 coverage
401(k) with immediate eligibility and company match...
The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.
Partially paid parental leave for eligible employees.
Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, as well as identity theft protection and pet insurance.
Equal Employment Opportunity
Reasonable Accommodations
We are committed to providing reasonable accommodations to individuals with disabilities and to applicants with sincerely held religious beliefs, practices, or observances. If you require assistance or accommodation during the application or interview process, please contac
Benefits
Health insuranceDental insuranceVision insurance401(k)Paid time offParental leave
Additional Information
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
Immatics · Houston