Senior Operational Quality Assurance Specialist
Immatics
JoinImmaticsandshape 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-edgescience and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCRbispecifics. Why Join Us Innovative Environment: Help topioneeradvancementsin cancer immunotherapy. Collaborative Culture: Be part ofa diverse team dedicated to your professionalgrowth. Global Impact: Contribute to therapies thatmakealasting impactonpatientsglobally. Role Overview Weareseekinga Senior Operational Quality Assurance Specialist to support ourOperational Quality Assurance & Systemsteam.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 upholdhigh standardsin a regulated environment. Schedule 0700–1530; Monday to Friday Reports to Senior Operational QualityAssurance Manager Location 13203Murphy 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 PreferredQualifications 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 In thisrole youwill 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 Comprehensive Benefits Competitive rates forHealth, Dental, and Vision Insurance 4 weeks ofvacation,granted up front each year and prorated for firstand lastyear ofemployment. 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 match100% of your contributions upto3% of yourbase salaryfor the first two yearsof employment, 4% foryears 2-3 of employment, and up to5%of your salaryfrom the fourth year onward of continued employment. Partiallypaidparentalleavefor eligible employees. Additionalvoluntary employee-paidbenefits and services,includingaccident,hospitalindemnity, andcriticalillnessinsurance, as well as identitytheftprotection andpetinsurance. Equal Employment Opportunity 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 (including pregnancy, childbirth, or related medical conditions), sexualorientation, gender identity or expression, national origin, ancestry, age, marital status, disability, geneticinformation, veteran status, or any other status protected by applicable law. Reasonable Accommodations We are committed to providing reasonable accommodations to individuals with disabilities and to applicants withsincerely heldreligious beliefs, practices, or observances. If you require assistance or accommodation during the application or interview process, please contact us at View email address on click.appcast.io. Work Authorization Applicants mustbe authorized towork in the United States without the need for current or future sponsorship. Visa sponsorships may beavailablefor certain roles. Pre-Employment Requirements Employment is contingent upon successful completion of a background check, referencechecksand pre-employment drug screening, wherepermittedby applicable law. For certain roles,additionalscreenings such as a credit check or motor vehicle record review may berequired, where job-related and consistent with business necessity. #J-18808-Ljbffr Immatics
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