Senior Operational Quality Assurance Specialist

Join Immaticsandshape thefuture ofcancerimmunotherapy; one patient at atime!

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 TCRbispecifics.

• Innovative Environment: Help topioneeradvancementsin cancer immunotherapy.
• Collaborative Culture: Be part ofa diverse team dedicated to your professional growth.
• Global Impact: Contribute to therapies thatmakealasting impactonpatientsglobally.

Weareseekinga Senior Operational Quality Assurance Specialist to support our Operational Quality Assurance & System steam.

This roleis responsible forensuringquality and compliance across manufacturing and CMC activities by conducting internal audits and supporting batch and material release processes. You willmaintainand manage key documentation, including standard operating procedures, work instructions, lab records, and manufacturing data, while helping uphold high standards in a regulated environment.

0700–1530;
Monday to Friday

Senior Operational Quality Assurance Manager

13203

Murphy Road Suite 100 Stafford, TX 77477

• 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’sor 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

• 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

• Competitive rates for Health, Dental, and Vision Insurance
• 4 weeks of vacation,granted up front each year and prorated for firstand lastyear of employment.
• 12 company paid holidays
• 7daysof sick time
• 100% employer-paidlifeinsuranceup toat 1x annual salary, up to one hundred thousand dollars
• 100% employer-paidshort- andlong-Termdisabilitycoverage
• 401(k) withimmediateeligibilityandcompany match…
• The company will match
  100% of your contributions upto 3% of yourbase salaryfor the first two yearsof employment, 4% foryears 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.
• Partiallypaidparentalleavefor eligible employees.
• Additional voluntary employee-paid benefits and services,includingaccident,hospital indemnity, andcriticalillnessinsurance, as well as identitytheftprotection andpetinsurance.

We are an equal opportunity employer and are committed to building a diverse and inclusive workplace. We consider all qualified applicants for employment without regard torace, color, religion, sex…