Manager, Quality Assurance Validation

Immatics•Houston, TX

1d•Remote

About The Position

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

Requirements

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, matrixed environment and manage competing priorities.

Nice To Haves

Master’s degree in Engineering, Computer Science, Life Sciences, or related field.
Experience in a wide variety of documents (creation/contribution) supporting qualification, validation, and release of pieces of equipment for quality control, or production (clinical and/or GMP commercial) within biopharma regulated settings.
Experience in audit and inspections within regulated settings.
Experience in Quality Assurance Release responsibilities within regulated settings.
Experienced in Software application deployments and administration.
Experience with IT infrastructure, computer/digital systems, and software solution deployments for biopharmaceutical business operations.
Contributed to manufacturing site deployment activities in the biopharmaceutical industry.
Experience in project management for operational excellence and lean concepts in the regulated pharmaceutical industry.
Willingness to be located onsite in Stafford is preferred although not required.

Responsibilities

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

Benefits

Comprehensive Benefits: Competitive rates for Health, Dental, and Vision Insurance
4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment. Sick Time Off – 56 hours
12 Paid Holidays
100% Employer-Paid Life Insurance up to at 1x annual salary
100% Employer Paid Short- and Long-Term Disability Coverage
401(k) with Immediate Eligibility & company match… You are eligible for 401(k) plan participation as of your first paycheck. 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. (3 weeks)
Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness
Employee Paid Identity Theft Protection and Pet Insurance.
Professional Growth: Opportunities to work with leading experts in the field of T-cell immunotherapy.
Company provided learning and development opportunities
Fast paced, high demand collaborative and dynamic environment.