Top 21575 Gcp Jobs | SimplyHired

Auditor - GCP
CSL Behring —King of Prussia, PA
- Full-time
- Up to 50% travel
- Bachelor of Science
- Mid-level
GCP Cloud Architect
Yoh, A Day & Zimmermann Company —Seattle, WA
- $154,000 - $220,000 a year
- Full-time
- 5 years
- Office
- Fair chance
- Health savings account
- Disability insurance
Quick Apply
Principal Investigator
Care Access —Houston, TX
- $200,000 - $400,000 a year
- Medicine
- Pass drug screening
- Travel
- Health savings account
- Paid holidays
Penetration Tester
OSec —Remote
- Full-time
- Remote
- Azure
- Mid-level
- Software development experience
- Health insurance
- 401(k)
Quick Apply
BA/BSA
Ukrish —Remote
- $45 - $55 an hour
- Full-time
- Remote
- Microsoft Outlook
- 8 years
- SQL
Quick Apply
AI Solutions Architect (Part-Time)
Teiva Systems —Remote
- Part-time
- Remote
- Azure
- System design
- English
- Flexible schedule
QA Manager, GCP
Sobi —San Diego, CA
- $112,000 - $153,000 a year
- Full-time
- Remote
- 5 years
- Senior level
- Health insurance
Quick Apply
Study Startup & Essential Documents Specialist
IUVO BIOSCIENCE OPERATIONS, LLC —Remote
- $65,000 - $80,000 a year
- Remote
- Microsoft Excel
- Microsoft Outlook
- Computer literacy
Quick Apply
In-House Clinical Research Associate
IUVO BIOSCIENCE OPERATIONS, LLC —Remote
- $78,000 - $90,000 a year
- Remote
- Nursing
- Microsoft Excel
- Microsoft Outlook
Quick Apply
Clinical Site Relationship Manager
IUVO BIOSCIENCE OPERATIONS, LLC —Remote
- $100,000 - $145,000 a year
- Remote
- Nursing
- Microsoft Excel
- Microsoft Outlook
Quick Apply
Quality Assurance Specialist (GCP/GLP)
Pharmaron —Germantown, MD
- Full-time
- Mid-level
- Bachelor's degree
- Communication skills
Quick Apply
VP, Professional Services
Vanta —Remote
- $303,000 - $406,000 a year
- Full-time
- Remote
- Azure
- HIPAA
- AWS
- Commuter assistance
- Paid parental leave
API testing,JMeter,GCP
Vytwo —Dallas, TX
- $55 an hour
- Full-time
- Mid-level
- 3 years
- JavaScript
Quick Apply
Clinical Study Manager
IUVO BIOSCIENCE OPERATIONS, LLC —Remote
- $100,000 - $150,000 a year
- Remote
- Microsoft Outlook
- Computer literacy
- Basic math
Quick Apply
Associate Director, Clinical Quality Assurance
Vera Therapeutics, Inc. —Remote
- $140,000 - $210,000 a year
- Remote
- 8 years
- Bachelor's degree
- Continuous improvement
- Paid holidays
- Health insurance
Quality Operations Program Manager - Document Control
Veeva Systems —Remote
- $100,000 - $150,000 a year
- Full-time
- Remote
- 5 years
- Bachelor of Science
- Bachelor's degree
- Paid holidays
- Health insurance
Python/GenAI Solutions Architect (USA, Remote)
Provectus —Remote
- Full-time
- Remote
- Public speaking
- English
- SQL
- Dental insurance
- Vision insurance
Quick Apply
Enterprise Solutions Engineer - Retail Tech
Simbe Robotics —Remote
- $130,000 - $165,000 a year
- Full-time
- Remote
- Computer science
- Azure
- Computer Science
Regional Project Lead
PSI CRO —Remote
- Full-time
- Remote
- English
- Microsoft Office
- Senior level
Quick Apply
Director, Quality Systems and Compliance
Loyal —Remote
- $180,000 - $220,000 a year
- Remote
- Bachelor's degree
- Experience equivalent to degree accepted
- Senior level
- Paid holidays
- Health insurance
8d

I want to receive the latest job alert for Gcp

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Auditor - GCP

CSL Behring -
King of Prussia, PA

Apply Now

Job Details

Full-time

Qualifications

Quality control corrective actions
Data integrity assurance
Biology
Bachelor's degree in biological science
Risk management compliance audits
Risk-based auditing
Clinical compliance checks
Data analysis reporting
Research ethical considerations
Audit report preparation
Clinical trial risk management
Clinical research audit management
Bachelor of Science
Corrective and preventive actions (CAPA)
FDA 21 CFR Part 11
Mid-level
Trend analysis
3 years
Quality control audit
Quality reports
Vendor compliance audits
Supplier audits
Clinical audit and monitoring
Data integrity and documentation
Analysis skills
ICH guidelines
Bachelor's degree
Quality risk management
Data quality monitoring
Clinical trial standard operating procedures

Full Job Description

The Opportunity:

This role serves as a GCP Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of clinical trial data and compliance with legal and corporate standards.

By conducting audits of our clinical investigator sites, external vendors, and internal trial management processes, you identify the findings and non-compliance trends that could impact the integrity of our clinical research. Seeking an experienced auditor who can navigate complex clinical environments and work collaboratively with stakeholders to develop corrective actions that ensure long-term systemic stability.

The Role:

Audit Execution: Conduct assigned external audits of clinical investigator sites, Contract Research Organizations (CROs), E-System providers, and Institutional Review Boards (IRBs/ECs).
Reporting & Risk Categorization: Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to trial conduct and data integrity.
Trend Analysis: Identify non-compliance trends and systematic risks within the Clinical (GCP) discipline, communicating these findings to line management and clinical functional leads to ensure trial robustness.
Continuous Improvement: Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions for clinical trial management and monitoring.
Regulatory Knowledge: Maintain up-to-date knowledge of global GCP regulations (ICH E6) and industry trends, identifying new requirements to ensure a high level of quality is maintained across all clinical development programs.

Skills and Experience:

Academic Background: BS degree in a relevant biological science, science, or related discipline
Professional Experience: 3+ years of Quality Assurance experience within a GCP-regulated environment, demonstrating a strong understanding of clinical trial phases, monitoring, and regulatory frameworks.
Audit Expertise: Experience in clinical audit and inspection management, with a clear understanding of the requirements for quality assurance in the clinical research discipline.
Communication Skills: Excellent interpersonal and negotiation skills, with the ability to work effectively with multinational clinical teams, investigators, and external CROs.
Working Knowledge of:
- ICH E6 (R3) Guideline
- 21 CFR Part 11 – Electronic Records; Electronic Signatures
- 21 CFR Part 50 – Protection of Human Subjects (Informed Consent)
- 21 CFR Part 312 – Investigational New Drug Application
- 21 CFR Part 812 – Investigational Device Exemptions
- Clinical Trials Regulation (CTR) (EU) No 536/2014
- Directive 2001/20/EC (Clinical Trial Directive)
- Directive 2005/28/EC (GCP Directive)
- Directive 2001/83/EC (Annex I)

Organizational Agility: Strong analytical and problem-solving skills, with the ability to work with limited supervision and manage a schedule that includes up to 50% travel.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Apply Now

Refine Your Search

Gcp jobs

Auditor - GCP

GCP Cloud Architect

Principal Investigator

Penetration Tester

BA/BSA

AI Solutions Architect (Part-Time)

QA Manager, GCP

Study Startup & Essential Documents Specialist

In-House Clinical Research Associate

Clinical Site Relationship Manager

Quality Assurance Specialist (GCP/GLP)

VP, Professional Services

API testing,JMeter,GCP

Clinical Study Manager

Associate Director, Clinical Quality Assurance

Quality Operations Program Manager - Document Control

Python/GenAI Solutions Architect (USA, Remote)

Enterprise Solutions Engineer - Retail Tech

Regional Project Lead

Director, Quality Systems and Compliance

I want to receive the latest job alert for Gcp

Related Searches

Explore jobs in more locations

About CSL Behring

Job Seeker Tools

Employer Tools

Browse

Stay Connected