Senior Operation Quality Assurance Specialist
ImmaticsAbout the role
Join Immatics and shape the future of cancer immunotherapy; one patient at a time!
Immatics is at the forefront of immunotherapy innovation, working to harness the power of T cells to transform cancer treatment.
Immatics is an exceptional clinical-stage biopharmaceutical company active in the discovery and development of T cells redirecting cancer immunotherapies.
We use these powerful T cells to develop groundbreaking immunotherapies that target cancer cells. We are dedicated to transforming cancer treatment and improving patient outcomes through cutting-edge research and advanced TCR technology.
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.
We are seeking an Senior Operational Quality Assurance Specialist to support our Global Quality Operations team. The Sr. OQA Specialist will be responsible to perform internal audits of manufacturing/CMC procedures; track and maintain standard operating procedures, work instructions, lab notebooks, manufacturing data and perform official batch and material release.
FLSA Classification: Salary/Exempt
Schedule: 8:00 AM – 5:00 PM; Monday to Friday; On-site
Reports to: Operational Quality Assurance Manager
Location: 13203 Murphy Road Suite 100 Stafford, TX 77477
What You’ll Do:
As an Sr. OQA Specialist , you will play a key role in:
Oversee the batch release process for cell and gene therapy products, ensuring compliance with regulatory requirements, industry standards, and company policies.
Review and approve batch records, analytical data, and associated documentation to ensure accuracy, completeness, and compliance with relevant regulations and guidelines.
Conduct thorough quality checks on cell and gene therapy products, including verification of identity, potency, purity, and safety attributes.
Collaborate closely with cross-functional teams, including manufacturing, quality control, regulatory affairs, and clinical operations, to address any quality issues, deviations, or non-conformances during batch release.
Ensure appropriate corrective and preventive actions are implemented for identified qua
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