ZipRecruiter

Log In

1

Gcp Quality Assurance Jobs (NOW HIRING)

Shionogi Inc.

Senior Manager, GCP QA

Florham Park, NJ

$135K - $165K/yr

We are seeking an experienced Senior Manager, GCP QA to join our team. This role is crucial for ensuring quality oversight of clinical studies and vendor programs, maintaining compliance with ICH GCP ...

Shionogi Inc.

Senior Manager, GCP QA

Florham Park, NJ

$135K - $165K/yr

Overview We are seeking an experienced Senior Manager, GCP QA to join our team. This role is crucial for ensuring quality oversight of clinical studies and vendor programs, maintaining compliance ...

Shionogi Inc.

Senior Manager, GCP QA

Florham Park, NJ · On-site

$135K - $165K/yr

Overview We are seeking an experienced Senior Manager, GCP QA to join our team. This role is crucial for ensuring quality oversight of clinical studies and vendor programs, maintaining compliance ...

Tempus

Director, (GCP) Quality Assurance

Chicago, IL · On-site

Oversee GCP framework for sponsored clinical trials to ensure required quality elements are strategically executed upon, risk-based, as appropriate. * Oversee the clinical QA audit program, including ...

Tempus

Director, (GCP) Quality Assurance

Chicago, IL · On-site +1

Oversee GCP framework for sponsored clinical trials to ensure required quality elements are strategically executed upon, risk-based, as appropriate. * Oversee the clinical QA audit program, including ...

Legend Biotech USA

Director of GCP Quality

Princeton, NJ · On-site

$122.72 - $184.09/hr

Furthermore, you will be taking up the role as GCP Inspection QA lead. The role requires profound understanding of how the GCP requirements are applied into practice, especially with focus on the ...

NCSL International

Director of GCP Quality

Princeton, NJ · On-site

$123.09 - $184.63/hr

Furthermore, you will be taking up the role as GCP Inspection QA lead. The role requires profound understanding of how the GCP requirements are applied into practice, especially with focus on the ...

next page

Showing results 1-20

All JobsGcp Quality Assurance Jobs

Gcp Quality Assurance information

See salary details

$38K

$118.1K

$179K

How much do gcp quality assurance jobs pay per year?

As of Aug 11, 2026, the average yearly pay for gcp quality assurance in the United States is $118,074.00, according to ZipRecruiter salary data. Most workers in this role earn between $83,000.00 and $144,500.00 per year, depending on experience, location, and employer.

What is a GCP Quality Assurance professional?

A GCP Quality Assurance (QA) professional ensures that clinical trials comply with Good Clinical Practice (GCP) guidelines and regulatory requirements. Their role involves auditing clinical trial processes, reviewing documentation, and helping organizations maintain the highest quality standards in clinical research. They work closely with clinical teams to identify and correct any compliance issues, ensuring the safety and integrity of trial data. This helps protect patient rights and upholds the credibility of research outcomes.

How does a GCP Quality Assurance professional typically collaborate with clinical research teams?

A GCP Quality Assurance professional works closely with clinical research teams to ensure all processes comply with Good Clinical Practice guidelines and regulatory standards. This involves regularly reviewing documentation, conducting audits, and providing guidance on protocol adherence. They often act as a bridge between research staff and regulatory bodies, clarifying compliance requirements and helping resolve any issues that arise. Strong communication and organizational skills are essential for fostering collaboration and maintaining the integrity of clinical trials.

What is the difference between Gcp Quality Assurance vs Cloud Quality Engineer?

AspectGcp Quality AssuranceCloud Quality Engineer
CertificationsGCP certifications, QA certificationsGCP certifications, QA certifications
Work EnvironmentCloud platforms, testing environmentsCloud platforms, testing and automation
Industry UsageTech, cloud service providersTech, cloud service providers

Gcp Quality Assurance focuses on testing and ensuring the quality of applications on Google Cloud Platform, emphasizing manual and automated testing processes. Cloud Quality Engineers also work on cloud environments but often include automation, deployment, and performance optimization. Both roles require similar certifications and are used within tech companies leveraging cloud services, but Gcp QA is more testing-centric, while Cloud Quality Engineers may have broader responsibilities.

What are the key skills and qualifications needed to thrive as a GCP Quality Assurance professional?

To thrive as a GCP Quality Assurance professional, you need in-depth knowledge of Good Clinical Practice (GCP) guidelines, clinical trial processes, and relevant regulatory requirements, often backed by a degree in life sciences or related fields. Familiarity with quality management systems (QMS), audit tools, and certifications such as GCP or clinical research associate (CRA) credentials are typically necessary. Strong attention to detail, analytical thinking, and effective communication are crucial soft skills for managing compliance and collaborating with cross-functional teams. These competencies ensure clinical trials meet regulatory standards, maintain data integrity, and protect patient safety.
What cities are hiring for Gcp Quality Assurance jobs? Cities with the most Gcp Quality Assurance job openings:
What states have the most Gcp Quality Assurance jobs? States with the most job openings for Gcp Quality Assurance jobs include:
What job categories do people searching Gcp Quality Assurance jobs look for? The top searched job categories for Gcp Quality Assurance jobs are:
Gcp Quality Assurance jobs near you
Infographic showing various Gcp Quality Assurance job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 14% Part Time, 4% Contract, and 1% Nights. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $118,074 per year, or $56.8 per hour.

Director, GCP Quality Assurance

Beeline Medicines

Boston, MA • Hybrid

Full-time

Posted 25 days ago

Job description

Job Summary:

The Director, GCP Quality Assurance is responsible for providing strategic and operational Quality Assurance oversight for Good Clinical Practice (GCP) activities supporting the company's clinical development programs. This role ensures that clinical trials are conducted in compliance with applicable regulatory requirements, company policies, and global GCP standards, with a continuous state of inspection readiness.

The Director partners closely with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Data Management, and external service providers to implement a risk-based quality oversight model across the clinical lifecycle. The role is accountable for GCP quality systems, vendor oversight, audits, and inspection support, and plays a critical role in embedding quality by design into clinical development programs


Work Arrangement & Location: 

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week - currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.


Essential Duties and Responsibilities:

  • Develop and implement the GCP QA strategy aligned with clinical development objectives and global regulatory expectations
  • Serve as a key QA partner to Clinical Operations and cross-functional stakeholders on GCP compliance and quality risk management.
  • Promote a strong culture of quality, compliance, and continuous improvement across clinical programs
  • Oversee GCP quality systems including deviations, investigations, CAPAs, change control, documentation, and training related to clinical activities.
  • Ensure GCP processes are phase-appropriate, compliant, and scalable
  • Support the development, review, and approval of GCP-related SOPs, policies, and work instructions.
  • Provide QA oversight for GCP activities conducted internally and by CROs, vendors, and other service providers
  • Lead GCP vendor qualification, audit strategy, and ongoing oversight using risk-based principles.
  • Review and approve GCP-related quality agreements and vendor oversight plans
  • Plan and execute risk-based GCP audits, including CRO audits, investigator site audits, and system audits as applicable.
  • Lead GCP inspection readiness activities and serve as a primary QA contact during health authority inspections.
  • Coordinate inspection preparation, conduct, and follow-up, including responses to regulatory observations.
  • Ensure a sustainable state of inspection readiness across clinical programs.
  • Ensure critical-to-quality considerations are embedded in clinical trial design and execution.
  • Provide oversight of data integrity practices across GCP processes and systems.
  • Identify, assess, and proactively mitigate GCP compliance risks
  • Perform other duties and responsibilities as assigned


Qualifications:

  • Education: Bachelor's degree in a scientific or related discipline; advanced degree preferred.
  • 10+ years of experience in GCP Quality Assurance or Clinical Quality within a biotech or pharmaceutical environment.
  • Strong knowledge of global GCP regulations and clinical trial oversight requirements.
  • Demonstrated experience supporting regulatory inspections and audits.
  • Experience overseeing CROs and other GCP service providers.
  • Experience supporting late-stage or pivotal clinical trials.
  • Strong background in risk-based quality management and inspection readiness.
  • Skilled at influencing without authority; effectively engages senior scientific, clinical, and operational stakeholders to drive alignment on quality priorities and shared accountability for compliance
  • Able to serve as a primary quality representative in regulatory agency interactions and inspections, communicating the company's quality posture with confidence and credibility.
  • Strong cross-functional collaborator who proactively communicates quality risk, escalates issues with appropriate context and urgency, and fosters a culture of transparent, solution-oriented dialogue.

Apply