Senior Operational Quality Assurance Specialist

Senior Operational Quality Assurance SpecialistJoin 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 OverviewWe 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 FridayReports to: Senior Operational Quality Assurance ManagerLocation: 13203 Murphy Road Suite 100 Stafford, TX 77477Basic Qualifications:Bachelor's degree in pharmaceutical sciences, life sciences, bioengineering, or a related field4+ years of experience in quality assurance within biotechnology or pharmaceutical environments, including batch release activities4+ years of experience working in regulated environments with cGMP and GCP standardsDemonstrated experience reviewing batch records, analytical data, and technical documentation for product releaseProven experience managing deviations, investigations, and CAPA processesPreferred Qualifications:Advanced degree (Master's or higher) in pharmaceutical sciences, life sciences, bioengineering, or a related fieldExperience in cell and gene therapy or advanced therapeutics within a GMP-regulated environmentStrong knowledge of global regulatory requirements (e.g., FDA, EMA, ICH) for biologics or advanced therapiesAdvanced ability to interpret complex manufacturing and analytical data to support quality decisionsIn this role you will:Oversee batch release activities for cell and gene therapy products, ensuring compliance with regulatory requirements and company standardsReview and approve batch records, analytical data, and documentation for accuracy, completeness, and compliancePerform quality checks to verify product identity, potency, purity, and safety attributesCollaborate cross-functionally to resolve quality issues, deviations, and non-conformancesDrive CAPA implementation and support continuous improvement of batch release processesMaintain and update procedures and documentation in line with regulatory guidelines and best practicesSupport audits, inspections, and regulatory submissions, and provide guidance to junior QA team membersWhat 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 ImmaticsComprehensive Benefits:Competitive rates for Health, Dental, and Vision Insurance4 weeks of vacation, granted up front each year and prorated for first and last year of employment.12 company paid holidays7 days of sick time100% employer-paid life insurance up to at 1x annual salary, up to one hundred thousand dollars100% employer-paid short- and long-Term disability coverage401(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 OpportunityWe are an equal opportunity employer and are committed to building a diverse and inclusive workplace. We consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, national origin, ancestry, age, marital status, disability, genetic information, veteran status, or any other status protected by applicable law.Reasonable AccommodationsWe 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 contact us at View email address on click.appcast.io AuthorizationApplicants must be authorized to work in the United States without the need for current or future sponsorship. Visa sponsorships may be available for certain roles.Pre-Employment RequirementsEmployment is contingent upon successful completion of a background check, reference checks and pre-employment drug screening, where permitted by applicable law. For certain roles, additional screenings such as a credit check or motor vehicle record review may be required, where job-related and consistent with business necessity. Immatics