Senior QA Validation Specialist

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 a Senior Quality Assurance Validation Specialist to support our Quality Assurance Validation team. The Senior Quality Assurance Validation Specialist will be a Subject Matter Expert in quality matters in the biopharmaceutical industry: this role serves as on-site QA representative in the U.S. based QA Validation team to handle commissioning, qualification and validation (CQV) activities. Specialist support covers multiple aspects in the Validation Lifecycle Management System (VLMS) from clinical phase toward commercialization including but not limited to quality oversight in equipment validation, analytical method validation and manufacturing process validation.  

FLSA Classification: Salary/ Exempt 
Schedule: 8:00 AM – 5:00 PM; Monday to Friday; On-site (Overtime hours on a business need basis)
Reports to: Manager, QA Validation 
Location: 13203 Murphy Road Suite 100 Stafford, TX 77477 

What You’ll Do:

As a Senior Quality Assurance Validation Specialist, you will play a key role in supporting our validation operations: 

• QA Review of validation documents including User Requirement Specifications, Design Verifications, Risk Assessments, Validation Plans, Qualification Protocols, Validation Reports.
• Quickly recognize, implement, and enforce compliance with applicable regulations,
• Propose best practices based on industry standards & guidance as well as state-of-the-art in the field of Cell Therapy (e.g. Adoptive Cell Therapy).
• Facilitate cross-functional teamwork with workstream’s stakeholders including harmonization and alignment of own QA Validation deliverables with U.S. QA Validation Management, Global Quality Operations and cross-functional Leadership.
• QA review representative for pre- and post-execution deliverables of validation related documents which may focus on company’s assets such as computerized systems, production process equipment, laboratory method studies, facilities and IT infrastructure in scope for GxP matters.
• Review Procedures such as Operational, Maintenance Cleaning documents (OMC) with focus on quality requirements and good documentation practices.
• Review deliverables from Quality Management Systems under VLMS, Change Control and Audits.
• Supports Project Management with Quality focus, Data Management, Digitalization initiatives, Business Continuity and Archival Business Processes.

Secondary Functions:

Secondary functions, ad-hoc or in case of need as directed by line manager, QA Validation:

• Support the Operational Quality Assurance Systems organization.
• Support Quality initiatives.
• Support Operational Excellence and Lean concepts

Required Experience and Education:

• At least 4 + years' experience in a related role
• Batchelor's degree in Computer Science, Life Sciences, or Engineering
• Able to work on-site: work includes traveling between different local collaborating U.S. sites and able to work in different working environments incl. office space, controlled rooms (laboratory, production facility).
• Shows can-do attitude, analytical and effective problem-solving skills (e.g. root cause analysis), attention to detail, high level of accuracy, flexible reasoning, ability to prioritize, critical thinker, high performing individual under tight timelines.
• Shows strong verbal and written communication and excellent technical writing including proficient use of Microsoft Excel, Word, and Power Point.
• Possess scientific, technical background with experience in Biotechnology, Engineering, Computer Science or related field as well as work experience in related Biopharma industry or similar regulated settings.
• Advanced understanding of CQV and Lifecycle Pillars, which may include