Manager, Quality Assurance Validation

Join 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.

We are seeking a Manager, QA Validation to provide Quality Assurance oversight of global computerized systems supporting GxP operations, including but not limited to SAP (ERP), CGTO (cell and gene therapy orchestration), MES (Manufacturing Execution Systems), LIMS (Laboratory Information Management Systems) and others. The role ensures that the systems are validated, maintained, and operated in compliance with global regulatory requirements, internal quality standards, and data integrity principles throughout their lifecycle.

This position will play a key role in the governance, risk-based validation, and lifecycle management of enterprise systems that support manufacturing, testing, supply chain, and quality management processes for Cell and Gene Therapy (CGT).

FLSA Classification:
Salary, Exempt

Schedule:

8:00 AM - 5:00 PM;
Monday to Friday;
Remote

Reports to:

Senior CSV Quality Manager

Location:

Fully Remote

What You'll Do:

As a Manager, QA Validation, you will play a key role in supporting our quality assurance validation team:

* Provide QA oversight for validation and revalidation activities of enterprise GxP systems (e.g. SAP, MES, LIMS) across the system development life cycle (SDLC).

* Ensure business processes are harmonized for inter-departmental digital system implementations.

* Provide Insight and guidance for effective implementation of inter-departmental business processes related to quality control and manufacturing.

* Provide validation strategies for complex systems in compliance with risk management and GAMP principles.

* Review and approve validation deliverables, including User Requirements Specifications (URS), Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, and Validation Summary Reports.

* Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable FDA/EMA/ICH guidance.

* Support implementation and qualification of new system functionalities, integrations, and upgrades under change control.

* Oversee periodic review and system retirement/decommissioning activities to maintain validation status and data integrity.

* Serve as QA approver for key validation and system lifecycle documents within global enterprise systems.

* Ensure adherence to internal policies, procedures, and validation master plans.

* Support development and continuous improvement of Computerized System Validation (CSV) and Computer Software Assurance (CSA) processes.

* Partner with IT, Manufacturing, Quality Control, and Business Process Owners to ensure system compliance and readiness for inspection.

* Mentor validation specialists and provide training on QA validation procedures and regulatory compliance.

Secondary Functions:

* Support needed within cross functional teams as CSV or QA role to help keep global application implementations on track.

Required Experience and

Education:

* At least 8 years' experience in a related role.

* Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.

* Prior experience with systems like LIMS, QMS, MES, ERP and applicable interfaces.

* Strong understanding of GAMP 5, 21 CFR Part 11, Annex 11, FDA/EMA guidance, and data integrity.

* Excellent understanding of validation lifecycle management and computerized system governance.

* Strong written and verbal communication skills with the ability to influence cross-functional teams.

* Detail-oriented with strong analytical and problem-solving skills.

* Proven ability to work in a global,…