Manager, Quality Assurance Validation
Immatics
full-time
Posted on:
Location Type: Remote
Location: Texas • United States
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About the role
- 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
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
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
- Partially paid Parental Leave for eligible employees
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
QA oversightvalidation strategiesrisk managementGAMP principlesUser Requirements SpecificationsValidation PlansRisk AssessmentsIQ/OQ/PQ protocolsComputerized System ValidationComputer Software Assurance
Soft skills
communication skillsanalytical skillsproblem-solving skillsdetail-orientedmentoringinfluencingcross-functional collaborationtrainingorganizational skillsability to manage competing priorities