Manager, Quality Assurance Validation
ImmaticsJoin 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, matrixed environment and manage competing priorities.
Preferred Experience and Education:
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.
Competencies
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.
Work Environment:
This position works in a typical office and/or lab and/or manufacturing clean room environment and/or other supporting facility areas with moderate noise levels and uses phone, computer, office equipment and supplies on a regular basis.
Travel required: up to 10% travel within United States and potentially to Germany.
Physical demands:
Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.
Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.
Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.
Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object – usually by holding it in the hands or arms but may occur on the shoulder.
Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
Pushing - Exerting force upon an object so that the object moves away from the object.
Pulling - Exerting force upon an object so that the object moves toward the force.
Sitting – remaining in a sitting position for at least 50% of the time.
Standing/Walking - remain on one's feet in an upright position at a workstation.
Stooping – occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.
Work authorization/security clearance requirements:
Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment
Affirmative Action/EEO statement:
Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs.
What 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 Immatics
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.