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Full Time Gxp Systems Jobs (NOW HIRING)

Alliance Biotech Solutions LLC

CSV Engineer

Raleigh, NC · On-site

... GxP computerized systems. · Partner with software developers, data engineers, IT, Quality, and ... Industry competitive wage as a full-time employee * Flexible Paid Time Off * Bonus plans * Medical ...

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Full Time Gxp Systems information

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$46K

$102.1K

$153K

How much do full time gxp systems jobs pay per year?

As of Sep 2, 2026, the average yearly pay for full time 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 GxP systems?

GxP systems are specialized software and processes used in industries like pharmaceuticals, biotechnology, and healthcare to ensure compliance with regulatory standards such as Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP). A full-time GxP systems role typically involves maintaining, validating, and supporting these systems to ensure they meet strict quality and compliance requirements. Professionals in this role work closely with quality assurance, IT, and regulatory teams to ensure data integrity and regulatory compliance throughout the product lifecycle.

What are the key skills and qualifications needed to thrive as a full time GxP Systems professional?

To thrive as a Full Time GxP Systems professional, you need a solid background in computer science or life sciences, experience with regulatory compliance (such as FDA, EMA), and knowledge of Good Practice (GxP) guidelines. Familiarity with validated systems, electronic records management tools, and common industry software like Veeva Vault or SAP is typically required. Attention to detail, strong problem-solving skills, and the ability to communicate effectively with cross-functional teams set top candidates apart. These competencies ensure systems are compliant, reliable, and support the integrity of regulated processes within the life sciences industry.

What are some common challenges faced by professionals working in full time GxP Systems roles, and how can they be addressed?

Professionals in full-time GxP Systems roles often face challenges related to maintaining regulatory compliance in a constantly evolving landscape. Staying current with global regulations, ensuring data integrity, and managing system validation can be demanding. Collaboration with quality assurance, IT, and business stakeholders is crucial to anticipate compliance risks and implement effective controls. Regular training, robust documentation practices, and proactive system monitoring are key strategies to overcome these challenges and support successful audits and inspections.

What is the difference between Full Time Gxp Systems vs Gxp Compliance Specialist?

AspectFull Time Gxp SystemsGxp Compliance Specialist
CertificationsGxP-related certifications, Good Practice trainingGxP certifications, regulatory compliance training
Work EnvironmentPharmaceutical or biotech manufacturing facilities, laboratoriesRegulatory departments, quality assurance teams
Employer & Industry UsagePharmaceutical companies, biotech firms, CROsRegulatory agencies, pharmaceutical companies

Full Time Gxp Systems roles focus on managing and maintaining GxP systems within manufacturing or laboratory environments, ensuring compliance and system integrity. Gxp Compliance Specialists primarily handle regulatory adherence, audits, and documentation. Both roles require similar certifications and work in related settings, but their core responsibilities differ in scope and focus.

What cities are hiring for Full Time Gxp Systems jobs?

Cities with the most Full Time Gxp Systems job openings:

What are the most commonly searched types of Gxp Systems jobs?

The most popular types of Gxp Systems jobs are:

What states have the most Full Time Gxp Systems jobs?

States with the most job openings for Full Time Gxp Systems jobs include:

Full Time Gxp Systems jobs near you

Senior Digital Systems Quality Assurance Engineer 3643945

Axiom Path

Bridgewater, NJ • Hybrid

$60 - $63/hr

Full-time

Re-posted 3 days ago

Job description

Be Part of a High-Performing Team

Join a patient-focused biopharmaceutical organization whose Quality and technology teams help ensure that the digital platforms supporting drug development, clinical operations, laboratory activities, and commercialization remain compliant and dependable.

This role sits within a collaborative Digital Systems Quality Assurance function that works closely with computerized system validation, Information Technology, business system owners, and external technology partners. The team supports a varied portfolio of enterprise, clinical, laboratory, cloud-based, and emerging AI-enabled GxP applications in a fast-moving regulated environment.

What’s In Store for You

  • Hybrid opportunity based in Bridgewater, New Jersey, with approximately one to two onsite days per week.
  • Full-time W2 consulting engagement supporting high-visibility digital quality initiatives.
  • Exposure to enterprise, clinical, laboratory, SaaS, cloud, and AI-enabled GxP platforms.
  • Opportunity to work across Quality, CSV, IT, business, and vendor teams.
  • Hands-on role with meaningful responsibility for patient safety, product quality, data integrity, and regulatory compliance.
  • Engagement: W2 only; no C2C or 1099 arrangements.

How You Will Make an Impact

  • Provide independent QA oversight for GxP computerized systems throughout implementation, operation, maintenance, enhancement, and retirement.
  • Help ensure that enterprise, clinical, and laboratory systems remain validated, compliant, and in a controlled state.
  • Review and approve validation and lifecycle deliverables for completeness, quality, procedural alignment, and regulatory compliance.
  • Apply 21 CFR Part 11, EU GMP Annex 11, ISPE GAMP 5, and risk-based validation principles to computerized systems and system changes.
  • Evaluate patient-safety, product-quality, data-integrity, and compliance risks associated with new systems, enhancements, and operational changes.
  • Review change controls, deviations, CAPAs, periodic reviews, supplier documentation, and other quality records.
  • Partner with CSV, IT, business system owners, and vendors to develop practical solutions that support business objectives without compromising quality.
  • Support inspection readiness, supplier qualification, regulatory audits, and ongoing lifecycle compliance.
  • Provide quality oversight for SaaS, cloud-hosted, and AI-enabled GxP systems.
  • Help define appropriate controls and validation evidence for AI solutions used to support GxP activities and decision-making.
  • Contribute to procedures, work instructions, training, and continuous improvements related to digital quality and computerized system lifecycle management.

Do You Bring Proven Success in Digital Systems Quality Assurance?

  • Bachelor’s degree in life sciences, engineering, computer science, or a related field preferred.
  • Five or more years of directly relevant Quality Assurance or computerized system validation experience in an FDA-regulated pharmaceutical or biotechnology environment; seven or more years preferred.
  • Hands-on experience providing QA oversight for GxP computerized systems.
  • Thorough working knowledge of 21 CFR Part 11 and EU GMP Annex 11.
  • Strong understanding of ISPE GAMP 5 and risk-based computerized system lifecycle principles.
  • Experience reviewing validation plans, requirements, specifications, protocols, test scripts, traceability documentation, and summary reports.
  • Experience evaluating computerized system risks related to patient safety, product quality, and data integrity.
  • Working knowledge of FDA Computer Software Assurance principles.
  • Experience with change control, deviations, CAPAs, periodic reviews, supplier quality, or inspection readiness.
  • Experience supporting enterprise, clinical, or laboratory GxP platforms.
  • Familiarity with systems such as Veeva Vault, ServiceNow, Qlik, Entra ID, EDC, IRT, eTMF, CTMS, LIMS, CDS, ELN, or Empower is beneficial.
  • Understanding of SaaS and cloud-hosted system quality oversight.
  • Awareness of validation and control principles for AI-enabled GxP systems is preferred.
  • ASQ CSQE, CQA, or CQE certification is beneficial.
  • Strong critical-thinking, collaboration, communication, accountability, and stakeholder-management skills.
  • Ability to work independently in a hands-on role while constructively challenging stakeholders when quality or compliance risks arise.