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Full Time Gxp Systems Jobs in California (NOW HIRING)

WinWire

Business Analyst

Foster City, CA · On-site

Job Type : Full-Time / Contract Location : Foster City, CA We are seeking a Business Analyst with ... Must understand GXP system validation process and familiar with AWS environments * Experience ...

Nihon Kohden USA

Quality Systems Manager

Irvine, CA · On-site

$100K - $145K/yr

Strong knowledge of GxP, ISO 13485, ISO 14971, and FDA 21 CFR 820. * Able to apply Canadian Medical ... The regular hours for this full-time position are 8:00 a.m. to 5:00 p.m., Monday-Friday, unless ...

Nihon Kohden America

Quality Systems Manager

Irvine, CA · On-site

$100K - $145K/yr

Strong knowledge of GxP, ISO 13485, ISO 14971, and FDA 21 CFR 820. * Able to apply Canadian Medical ... The regular hours for this full-time position are 8:00 a.m. to 5:00 p.m., Monday-Friday, unless ...

Nihon Kohden America, LLC

Quality Systems Manager

Irvine, CA · On-site

$100K - $145K/yr

Strong knowledge of GxP, ISO 13485, ISO 14971, and FDA 21 CFR 820. * Able to apply Canadian Medical ... The regular hours for this full-time position are 8:00 a.m. to 5:00 p.m., Monday-Friday, unless ...

Nihon Kohden

Quality Systems Manager

Irvine, CA · On-site

$100K - $145K/yr

Strong knowledge of GxP, ISO 13485, ISO 14971, and FDA 21 CFR 820. * Able to apply Canadian Medical ... The regular hours for this full-time position are 8:00 a.m. to 5:00 p.m., Monday-Friday, unless ...

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All JobsGxp Systems JobsFull Time Gxp Systems JobsFull Time Gxp Systems Jobs in California

Full Time Gxp Systems information

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 are the most commonly searched types of Gxp Systems jobs in California?

The most popular types of Gxp Systems jobs in California are:

What cities in California are hiring for Full Time Gxp Systems jobs?

Cities in California with the most Full Time Gxp Systems job openings:

Full Time Gxp Systems jobs near you
Infographic showing various Full Time Gxp Systems job openings in California as of August 2026, with employment types broken down into 100% Full Time. Highlights an 80% In-person, 10% Hybrid, and 10% Remote job distribution.

Manager, Computer Systems Validation (CSV)

Corcept Therapeutics

Redwood City, CA

$160K - $189K/yr

Full-time

Posted 29 days ago

Job description

The Manager, Computer Systems Validation (CSV) will be a core member of the Quality Systems Technology team and responsible for the implementation, management, ongoing support and review of Corcept's internal GXP validated systems. This individual will ensure IT Quality and Risk Management standards are defined, understood, designed into work activity, and achieved. This position will manage day-to-day operations for IT Compliance and Risk Management, working closely with key stakeholders from business teams, particularly QA, heavily guiding business teams on validation principles and requirements throughout the system lifecycle. This role will ensure compliance risks are identified, mitigated, and managed appropriately.

Responsibilities:

  • Provide assessment/review/oversight for Enterprise / GXP computer systems validation (focus on Pharmaceutical Systems)  
  • Experienced in developing validation strategies and authoring validation documents such as validation master plans, data migration plans, protocols, reports, discrepancies    
  • Ensure compliance and the validated state of all GXP systems 
  • Provide validation guidance on data migration activities as needed
  • Provide IT assessment and approval for GXP computer system changes
  •  Develop and support testing of proposed changes in system development environments
  • Experience in authoring and managing documents such as change control, Risk Assessments, Validation Plans, User Requirements Specifications, Functional Specifications, qualification protocols (IQ/OQ/PQ), Traceability Matrix, system procedures, deviations and CAPAs
  • Coordinate and support vendor support release activities 
  • Support and provide guidance to cross-functional groups with GXP system implementation projects and ongoing validation needs including system enhancements, releases and revalidation
  • Responsible to manage external CSV consultants in CSV projects 
  • Responsible as interface between IT and QA 

Preferred Education and Experience:

  • 8+ years' experience in QA or Validation performing protocol review and approval associated with the implementation and maintenance of computerized systems in pharma/biotech environment 
  • Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 210, 211& 11, Annex 11, GAMP5, ICH Q9, Data Integrity, CSA 

Skills, Qualifications, or Technical Proficiencies:

  • Thorough understanding of validation/qualification and concepts as it applies to pharmaceutical quality systems 
  • Excellent communication skills with the ability to effectively communicate across organizational levels and functions 
  • Proficiency with Veeva QualityDocs / QMS and ComplianceWire 
  • Experience with CTMS and Regulatory systems  
  • Ability to manage external software and consultant vendors 

The pay range that the Company reasonably expects to pay for this headquarters-based position is $160,600 - $189,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.

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