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Immatics · 20 hours ago

Manager, Quality Assurance Validation

United States

Full-time

Remote

Mid, Senior Level, Lead/Staff

8+ years exp

Immatics is committed to making a meaningful impact on the lives of patients with cancer. The Manager, QA Validation will provide Quality Assurance oversight of global computerized systems supporting GxP operations and ensure compliance with global regulatory requirements and internal quality standards throughout their lifecycle.

Biotechnology

Comp. & Benefits

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

Qualification

QA oversightGxP systemsSAPLIMSGAMP 5Validation lifecycle managementAnalytical skillsCommunication skillsProblem-solving skillsProject management

Required

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

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

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.