GXP-Validation Analyst
Chicago, IL ยท On-site
GXP-Validation Analyst; Location: Chicago/Nearshore CST time PURPOSE OF THE POSITION * Consult ... Performing Compliance evaluation of procedures and systems wrt equipment, facilities and ...
Chicago, IL ยท On-site
GXP-Validation Analyst; Location: Chicago/Nearshore CST time PURPOSE OF THE POSITION * Consult ... Performing Compliance evaluation of procedures and systems wrt equipment, facilities and ...
Chicago, IL ยท On-site
GXP-Validation Analyst; Location: Chicago/Nearshore CST time PURPOSE OF THE POSITION * Consult ... Performing Compliance evaluation of procedures and systems wrt equipment, facilities and ...
Validated Systems Implementation: Manage the deployment of GxP-compliant systems, ensuring proper validation processes (e.g., IQ/OQ/PQ) and compliance with regulatory standards. Portal and Website ...
Validated Systems Implementation: Manage the deployment of GxP-compliant systems, ensuring proper validation processes (e.g., IQ/OQ/PQ) and compliance with regulatory standards. Portal and Website ...
The Manager of GxP Quality Systems will support Quality Management System processes, procedures, systems, training, and tools, ensuring quality and compliance are achieved and maintained across GxP ...
The Manager of GxP Quality Systems will support Quality Management System processes, procedures, systems, training, and tools, ensuring quality and compliance are achieved and maintained across GxP ...
Overview We are seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities across Pharmacovigilance (PV), Clinical, and Regulatory Affairs systems. This ...
Overview We are seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities across Pharmacovigilance (PV), Clinical, and Regulatory Affairs systems. This ...
CSV Consultant (Computer Systems Validation) Location: Redwood City, CA Type: Contract Job Summary We are seeking an experienced CSV Consultant to support validation activities across multiple GxP ...
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CSV Consultant (Computer Systems Validation) Location: Redwood City, CA Type: Contract Job Summary We are seeking an experienced CSV Consultant to support validation activities across multiple GxP ...
Bethesda, MD ยท Hybrid
$145K - $234K/yr
As Product Manager and System Owner, this role will have accountability for system reliability ... Ensure full GxP compliance and audit readiness, working in partnership with Quality, IT Compliance, ...
Bethesda, MD ยท Hybrid
$145K - $234K/yr
As Product Manager and System Owner, this role will have accountability for system reliability ... Ensure full GxP compliance and audit readiness, working in partnership with Quality, IT Compliance, ...
Overview We are seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities across Pharmacovigilance (PV), Clinical, and Regulatory Affairs systems. This ...
Overview We are seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities across Pharmacovigilance (PV), Clinical, and Regulatory Affairs systems. This ...
Cambridge, MA ยท Hybrid
$145K - $234K/yr
As Product Manager and System Owner, this role will have accountability for system reliability ... Ensure full GxP compliance and audit readiness, working in partnership with Quality, IT Compliance, ...
Cambridge, MA ยท Hybrid
$145K - $234K/yr
As Product Manager and System Owner, this role will have accountability for system reliability ... Ensure full GxP compliance and audit readiness, working in partnership with Quality, IT Compliance, ...
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 ...
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 ...
Cambridge, MA ยท Hybrid
$145K - $234K/yr
As Product Manager and System Owner, this role will have accountability for system reliability ... Ensure full GxP compliance and audit readiness, working in partnership with Quality, IT Compliance, ...
Cambridge, MA ยท Hybrid
$145K - $234K/yr
As Product Manager and System Owner, this role will have accountability for system reliability ... Ensure full GxP compliance and audit readiness, working in partnership with Quality, IT Compliance, ...
This role serves as a subject matter expert for GxP quality systems and is accountable for system governance, compliance, and operational excellence across electronic quality platforms. The Director ...
This role serves as a subject matter expert for GxP quality systems and is accountable for system governance, compliance, and operational excellence across electronic quality platforms. The Director ...
Provide Quality oversight for GxP systems change controls. Support validation planning, execution, approvals * Act as the Business Owner for Veeva QualityVault. Lead the optimization of modules ...
Provide Quality oversight for GxP systems change controls. Support validation planning, execution, approvals * Act as the Business Owner for Veeva QualityVault. Lead the optimization of modules ...
San Francisco, CA ยท On-site
This role serves as a subject matter expert for GxP quality systems and is accountable for system governance, compliance, and operational excellence across electronic quality platforms. The Director ...
San Francisco, CA ยท On-site
This role serves as a subject matter expert for GxP quality systems and is accountable for system governance, compliance, and operational excellence across electronic quality platforms. The Director ...
Waltham, MA ยท Hybrid
$122K - $150K/yr
The Manager of GxP Quality Systems will support Quality Management System processes, procedures, systems, training, and tools, ensuring quality and compliance are achieved and maintained across GxP ...
Waltham, MA ยท Hybrid
$122K - $150K/yr
The Manager of GxP Quality Systems will support Quality Management System processes, procedures, systems, training, and tools, ensuring quality and compliance are achieved and maintained across GxP ...
The role drives a risk-based approach to validation through CSA principles and frameworks such as GAMP 5 to ensure GxP systems meet intended use while driving efficiency and compliance with ...
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The role drives a risk-based approach to validation through CSA principles and frameworks such as GAMP 5 to ensure GxP systems meet intended use while driving efficiency and compliance with ...
Provide Quality Assurance oversight of CSV activities for internal and external GxP computerized systems, ensuring validation activities are conducted in compliance with regulatory requirements and ...
Provide Quality Assurance oversight of CSV activities for internal and external GxP computerized systems, ensuring validation activities are conducted in compliance with regulatory requirements and ...
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 ...
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 ...
The role drives a risk-based approach to validation through CSA principles and frameworks such as GAMP 5 to ensure GxP systems meet intended use while driving efficiency and compliance with ...
The role drives a risk-based approach to validation through CSA principles and frameworks such as GAMP 5 to ensure GxP systems meet intended use while driving efficiency and compliance with ...
Raritan, NJ ยท On-site
$73K - $95K/yr
Strong CSV and Quality expertise with ability to independently lead validation activities across the SDLC for GxP systems with minimal supervision. 7-10 years of relevant experience. Proven ...
Raritan, NJ ยท On-site
$73K - $95K/yr
Strong CSV and Quality expertise with ability to independently lead validation activities across the SDLC for GxP systems with minimal supervision. 7-10 years of relevant experience. Proven ...
King Of Prussia, PA ยท On-site
... GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document process Compliance Analysis Adept with ...
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King Of Prussia, PA ยท On-site
... GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document process Compliance Analysis Adept with ...
$46K - $55.7K
5% of jobs
$55.7K - $65.5K
6% of jobs
$65.5K - $75.2K
12% of jobs
$76.6K is the 25th percentile. Wages below this are outliers.
$75.2K - $84.9K
11% of jobs
$84.9K - $94.6K
12% of jobs
The median wage is $98.2K / yr.
$94.6K - $104.4K
12% of jobs
$104.4K - $114.1K
11% of jobs
$121.1K is the 75th percentile. Wages above this are outliers.
$114.1K - $123.8K
10% of jobs
$123.8K - $133.5K
9% of jobs
$133.5K - $143.3K
10% of jobs
$143.3K - $153K
4% of jobs
$46K
$102.1K
$153K
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.
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.
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.

Full-time
Posted 4 days ago