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Beedata

GXP Lab Systems Consultant

North Chicago, IL · On-site

AbbVie Pharmaceuticals GXP Lab Systems Consultant - ABBVJP00034455 Location: 1401 Sheridan Rd, North Chicago, IL 60064 . Position Summary The IT / Lab Systems Support Specialist is responsible for ...

Evotecgroup

IT Specialist III, GMP Systems

Redmond, WA

$115K - $126K/yr

Follow Computerized Systems Validation (CSV) process to build out and qualify/validate GxP systems. * Directly responsible for deployment, as well as authoring IT validation documents such as System ...

Evotec

IT Specialist III, GMP Systems

Redmond, WA · On-site

$115K - $126K/yr

Follow Computerized Systems Validation (CSV) process to build out and qualify/validate GxP systems. * Directly responsible for deployment, as well as authoring IT validation documents such as System ...

Evotec

IT Specialist III, GMP Systems

Redmond, WA

$115K - $126K/yr

Follow Computerized Systems Validation (CSV) process to build out and qualify/validate GxP systems. * Directly responsible for deployment, as well as authoring IT validation documents such as System ...

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How much do gxp systems jobs pay per year?

As of Jul 14, 2026, the average yearly pay for gxp systems in the United States is $102,067.00, according to ZipRecruiter salary data. Most workers in this role earn between $77,000.00 and $125,000.00 per year, depending on experience, location, and employer.

What are the main responsibilities of someone working in GxP Systems?

Professionals in GxP Systems are responsible for implementing, validating, and maintaining computerized systems used in regulated environments, ensuring these systems comply with industry regulations such as FDA, EMA, or ICH guidelines. Their daily tasks typically include managing system validation projects, performing risk assessments, handling documentation, supporting audits, and collaborating with IT, Quality Assurance, and business users. The role also involves troubleshooting issues, keeping up with regulatory updates, and providing user training. Given the critical nature of compliance in life sciences and healthcare, attention to detail and cross-functional teamwork are crucial for success.

What is a GxP Systems job?

A GxP Systems job involves managing, implementing, and maintaining computerized systems that comply with regulatory standards like FDA, EMA, and other industry guidelines. These systems support Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) in industries such as pharmaceuticals and biotechnology. Responsibilities typically include validation, documentation, compliance assessments, and ensuring data integrity. The role requires knowledge of regulatory requirements, IT systems, and quality assurance principles.

What are the key skills and qualifications needed to thrive in the Gxp Systems position, and why are they important?

To thrive in a GxP Systems role, strong knowledge of GxP (Good Practice) regulations, computer system validation (CSV), and IT compliance are essential, usually supported by a degree in a scientific or technical field. Familiarity with quality management systems (QMS), 21 CFR Part 11, audit processes, and common validation and documentation tools is typically required, and certifications such as PMP or GAMP can be advantageous. Excellent problem-solving, attention to detail, and communication skills help professionals manage highly regulated projects and collaborate across departments. These capabilities are vital to ensure technology systems meet regulatory standards, reduce compliance risks, and maintain data integrity in regulated environments.

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Gxp Systems jobs near you
Infographic showing various Gxp Systems job openings in the United States as of July 2026, with employment types broken down into 2% Locum Tenens, 20% Internship, 60% As Needed, 16% Full Time, 1% Contract, and 1% Summer. Highlights an 88% Physical, 3% Hybrid, and 9% Remote job distribution, with an average salary of $102,067 per year, or $49.1 per hour.

Associate Director, Computer Systems Assurance (Quality)

Nurix

Brisbane, CA • On-site

Full-time

Re-posted 11 days ago

Job description

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix's dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine's next chapter with a new script to outmatch disease.
Position
The Senior Manager / Associate Director, Computer Systems Assurance (CSA) is an important technical and operational leader within the Nurix Quality Systems organization, responsible for owning and advancing Nurix's computer systems assurance program. As a virtual drug developer, Nurix operates through a lean internal infrastructure and relies on a curated ecosystem of Software-as-a-Service (SaaS) and cloud-hosted platforms to support GxP-regulated activities across clinical development, quality operations, manufacturing oversight, and regulatory submissions. This role will serve as the primary subject matter expert and program owner for all CSA and computerized system validation (CSV) activities at Nurix.
Reporting to the Vice President / Senior Director, Quality Systems, this individual will establish and maintain Nurix's risk-based CSA framework aligned with current regulatory expectations, including the FDA's 2022 guidance on computer software assurance, GAMP 5 (2nd edition), and applicable 21 CFR Part 11 and Annex 11 requirements. The role requires an individual who combines deep technical knowledge of GxP computerized systems with practical experience in SaaS and cloud-based platform qualification, and who can translate regulatory requirements into pragmatic, fit-for-purpose validation approaches that support a modern, agile biotech environment. This is a high-impact, program-ownership role requiring both strategic vision and hands-on execution. The successful candidate will work closely with Quality, IT, Regulatory Affairs, CMC, Clinical Operations, and external vendors to ensure that all GxP-critical systems are appropriately assessed, validated, and maintained in a compliant state. The individual will champion a risk-based, science-driven approach to CSA across the organization.
Responsibilities
CSA Program Ownership and Strategy
  • Own and maintain Nurix's Computer Systems Assurance policy framework, SOPs, and risk-based validation strategy, aligned with FDA CSA guidance (2022), GAMP 5 (2nd edition), 21 CFR Part 11, EU Annex 11, and applicable ICH guidelines.
  • Define and implement a fit-for-purpose, risk-tiered approach to system qualification for SaaS and cloud-hosted GxP applications, recognizing the vendor-managed nature of modern software platforms.
  • Maintain the GxP system inventory; conduct and document periodic system risk assessments to classify systems and determine appropriate validation scope and rigor.
  • Establish and maintain processes for vendor assessment, including review of vendor SOC 2 reports, quality agreements, and audit strategies appropriate for SaaS providers.
  • Drive continuous improvement of the CSA program through benchmarking, regulatory intelligence, and adoption of industry best practices.
System Validation and Qualification Execution
  • Lead and execute validation activities for GxP SaaS platforms including, but not limited to, eQMS (e.g., Veeva Vault), electronic document management, clinical data management, regulatory information management, and laboratory information systems.
  • Author and review validation documentation including Validation Master Plans (VMPs), User Requirements Specifications (URS), Risk Assessments, Vendor Assessments, Validation Protocols (IQ/OQ/PQ), Traceability Matrices, and Validation Summary Reports.
  • Manage validation activities associated with system implementations, major configuration changes, upgrades, and periodic re-validation reviews, applying critical thinking to scope validation effort proportionate to system risk and change impact.
  • Coordinate validation testing activities with cross-functional stakeholders; ensure test scripts are appropriately designed to demonstrate fitness for intended use.
  • Review and approve validation deliverables prepared by internal teams, vendors, or external validation consultants.
21 CFR Part 11 and Data Integrity
  • Serve as the internal subject matter expert for 21 CFR Part 11 and EU Annex 11 requirements; assess systems for compliance and provide guidance to cross-functional partners.
  • Partner with IT and system owners to ensure electronic records and electronic signature controls are properly implemented and documented in all GxP systems.
  • Support data integrity assessments and remediation initiatives; apply ALCOA+ principles to guide compliant system design and use.
Change Management and Periodic Review
  • Manage the computerized systems change control process; evaluate proposed changes for validation impact and establish appropriate assessment, testing, and documentation requirements prior to implementation.
  • Own and execute the periodic review program for validated GxP systems; assess continued fitness for intended use and compliance with current regulatory expectations.
  • Maintain validation status documentation and ensure validation files are audit-ready at all times.
Inspection Readiness and Regulatory Support
  • Support preparation for regulatory agency inspections; serve as the CSA subject matter expert during FDA, EMA, and other Health Authority inspections and ensure validation documentation is complete, current, and accessible.
  • Contribute to relevant sections of regulatory submissions and respond to agency questions related to computerized systems and data integrity.
  • Monitor evolving regulatory guidance and industry standards related to CSA, CSV, data integrity, and cloud-based systems; proactively adapt Nurix's program to reflect current expectations.
Cross-Functional Partnership and Training
  • Serve as the primary point of contact and internal consultant for all GxP system owners across Quality, IT, Regulatory Affairs, CMC, and Clinical Operations.
  • Develop and deliver CSA training for system owners, end users, and other stakeholders to build organizational capability and awareness.
  • Partner with IT and vendor project teams to embed validation requirements early in system selection and implementation processes.
Required Qualifications
  • Bachelor's degree in computer science, information systems, life sciences, pharmaceutical sciences, or a related field.
  • 7-10+ years of progressive experience in computer systems validation and/or computer systems assurance in a GxP-regulated pharmaceutical, biopharmaceutical, or biotechnology environment.
  • Demonstrated expertise in current regulatory requirements for computerized systems, including FDA 21 CFR Part 11, EU Annex 11, FDA CSA guidance (2022), and GAMP 5 (2nd edition).
  • Hands-on experience validating SaaS and cloud-hosted GxP platforms; understanding of vendor-managed environments and shared responsibility models.
  • Proficiency authoring and reviewing CSA/CSV deliverables: VMPs, URSs, Risk Assessments, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
  • Strong working knowledge of data integrity principles (ALCOA+) and their application to electronic records management and GxP system design.
  • Experience managing system change control and periodic review programs for validated GxP systems.
  • Ability to operate as both program owner and individual contributor in a lean, virtual organizational model; comfortable managing validation activities without a large internal support team.
  • Excellent written and verbal communication skills; able to translate complex technical and regulatory requirements into practical guidance for diverse stakeholders.
  • Strong organizational skills and attention to detail; demonstrated ability to manage multiple concurrent programs and priorities in a fast-paced environment.
Preferred Qualifications
  • Experience with eQMS validation (e.g., Veeva Vault) and familiarity with Veeva's Qualified System approach and available supplier documentation.
  • Familiarity with clinical development platforms such as electronic data capture (EDC), regulatory information management (RIM), or clinical trial management systems (CTMS) in a validated context.
  • Experience supporting FDA, EMA, or equivalent Health Authority inspections as a CSA subject matter expert.
  • Exposure to laboratory informatics systems (LIMS, ELN) and their GxP qualification requirements.
  • Experience in a virtual or lean biotech environment managing validation activities through external vendors and consultants.
  • Working knowledge of cybersecurity frameworks and their intersection with GxP system compliance (e.g., NIST, SOC 2).
  • Advanced degree in a relevant scientific, engineering, or regulatory discipline.
Fit with Nurix Culture and Values
  • You know the regulations deeply and apply them with judgment, designing validation approaches that are rigorous where it matters and efficient everywhere else. You bring expertise with pragmatism -
  • You are comfortable as the go-to expert, driving the CSA program forward proactively rather than waiting for direction, and you take accountability for outcomesYou own the program -
  • You build trusted relationships across Quality, IT, and the business, and you understand that a well-designed, compliant systems environment is an enabler of Nurix's mission to develop important medicines for patients. You partner with purpose -

Location: Brisbane, CA - Onsite
Salary Ranges: Senior Manager, CSA(Quality) - $170,538 - $193,493
Associate Director, CSA(Quality) - $190,269 - $216,360
Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).

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