Senior Operational Quality Assurance Specialist

JoinImmaticsandshape thefuture ofcancerimmunotherapy; one patient at atime!

Immaticsis committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting ofPRAME a target expressed in more than 50 cancers. Ourcutting-edgescience and robust clinical pipeline form the broadestPRAMEfranchise with the mostPRAMEindications 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

WeareseekingaSenior Operational Quality Assurance Specialistto support ourOperational Quality Assurance & 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:; Monday to Friday

Reports to:Senior Operational QualityAssurance Manager

Location: 13203Murphy Road Suite 100 Stafford TX 77477

Basic Qualifications:

• Bachelors 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 (Mastersor 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

AtImmatics we believe in investing in our teams healthsafetyand you can expectif youjoinImmatics

Comprehensive Benefits:

• Competitive rates forHealth Dental and Vision Insurance
• 4 weeks ofvacationgranted 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 servicesincludingaccidenthospitalindemnity 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.

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 rolesadditionalscreenings such as a credit check or motor vehicle record review may berequired where job-related and consistent with business necessity.