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Commission Gcp Qa Jobs (NOW HIRING)

NCSL International

Director of GCP Quality

Princeton, NJ · On-site

$123.09 - $184.63/hr

  • Medical

  • Retirement

  • PTO

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 ...

Legend Biotech USA

Director of GCP Quality

Princeton, NJ · On-site

$122.72 - $184.09/hr

  • Medical

  • Retirement

  • PTO

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 ...

Spyre Therapeutics

Senior Manager, GCP Quality Assurance

$149/hr

  • Medical

  • Retirement

  • PTO

The Senior Manager, GCP Quality will support Clinical Quality Assurance (CQA) activities across Spyre's clinical development programs, including the planning and execution of audits, management of ...

Monte Rosa Therapeutics, Inc

Director Quality GCP

Boston, MA · On-site

$185K - $235K/yr

Provide QA GCP review and feedback on regulatory submissions. * Lead and participate in inspection readiness activities for regulatory inspections - both internally and at clinical sites. * Interface ...

Sobi

QA Manager, GCP

Raleigh, NC

$112K - $153K/yr

Ensuring quality oversight and quality assurance and quality by design activities related to GCP/GCLP area * Providing quality guidance and support for GCP/GCLP and GPP-related activities within Sobi ...

Sobi

QA Manager, GCP

Raleigh, NC · On-site

Ensuring quality oversight and quality assurance and quality by design activities related to GCP/GCLP area * Providing quality guidance and support for GCP/GCLP and GPP-related activities within Sobi ...

Sobi

QA Manager, GCP

Raleigh, NC · On-site

$112K - $153K/yr

Ensuring quality oversight and quality assurance and quality by design activities related to GCP/GCLP area * Providing quality guidance and support for GCP/GCLP and GPP-related activities within Sobi ...

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Commission Gcp Qa information

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How much do commission gcp qa jobs pay per hour?

As of Aug 20, 2026, the average hourly pay for commission gcp qa in the United States is $46.70, according to ZipRecruiter salary data. Most workers in this role earn between $29.81 and $62.02 per hour, depending on experience, location, and employer.

What is a Commission GCP QA?

A Commission GCP QA (Good Clinical Practice Quality Assurance) is a professional responsible for ensuring that clinical trials and studies comply with regulatory guidelines, ethical standards, and GCP regulations. They conduct audits, review documentation, and assess processes to ensure data integrity and patient safety. The 'commission' aspect often refers to working on a contract or project basis rather than as a full-time employee. Their work is crucial in maintaining the credibility and reliability of clinical research data.

What are the key skills and qualifications needed to thrive as a Commission GCP QA?

To thrive as a Commission GCP QA (Good Clinical Practice Quality Assurance), you need a solid background in clinical research, regulatory compliance, and GCP guidelines, typically supported by a life sciences degree and relevant QA experience. Familiarity with auditing tools, electronic trial master files (eTMF), and certifications such as RQAP-GCP or equivalent are commonly required. Strong attention to detail, analytical thinking, and effective communication skills are essential soft skills for this role. These competencies are crucial for ensuring that clinical trials adhere to regulatory standards, protect patient safety, and maintain data integrity.

What are some common challenges faced by a Commission GCP QA professional when ensuring compliance in complex clinical trials?

Commission GCP QA professionals often encounter challenges such as keeping up with evolving regulatory requirements, ensuring consistency in documentation across multiple trial sites, and managing communication between diverse teams. Navigating audits and inspections, particularly when trials are conducted internationally, can also be complex due to varying local regulations. Strong attention to detail, proactive problem-solving, and effective collaboration with clinical operations, data management, and regulatory affairs teams are essential to overcome these hurdles and maintain high compliance standards.

What is the difference between Commission Gcp Qa vs Cloud Quality Analyst?

AspectCommission Gcp QaCloud Quality Analyst
CertificationsGCP certifications, QA testing certificationsGCP certifications, QA testing certifications
Work EnvironmentCloud platforms, QA testing teamsCloud platforms, QA testing teams
Industry UsageTech companies using GCP for cloud solutionsTech companies focusing on cloud service quality
Primary FocusCommissioning and quality assurance of GCP projectsQuality assurance of cloud services and applications

Both roles involve quality assurance and GCP knowledge, but Commission Gcp Qa emphasizes commissioning processes within GCP projects, while Cloud Quality Analyst focuses broadly on cloud service quality across platforms. The roles often overlap but differ in scope and specific responsibilities.

What cities are hiring for Commission Gcp Qa jobs?

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What are the most commonly searched types of Gcp Qa jobs?

The most popular types of Gcp Qa jobs are:

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Commission Gcp Qa jobs near you
Infographic showing various Commission Gcp Qa job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 85% Full Time, 9% Part Time, and 5% Contract. Highlights an 57% Physical, 1% Hybrid, and 42% Remote job distribution, with an average salary of $97,144 per year, or $46.7 per hour.

Director / Senior Director, GCP Quality Assurance Lead (US/IL/EU)

Prilenia

Boston, MA

Full-time

Re-posted 13 days ago

Job description

About Prilenia

Prilenia Therapeutics, a clinical-stage biotechnology company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Director/Senior Director, GCP Quality Assurance Lead, to support programs in both Huntington's Disease and ALS.

We are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington's disease (HD) and amyotrophic lateral sclerosis (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is conducting global Phase 3 clinical trials in both HD and ALS.

Pridopidine has the potential to be a pivotal treatment to address HD and ALS disease progression. Prilenia believes pridopidine's novel mechanism of action as a Sigma-1 receptor agonist also gives it potential in numerous other neurodegenerative and neurodevelopmental conditions.

To learn more about our story and company culture, visit us at https://Prilenia.com 

 
About the role

The Director/Sr. Dir, GCP Quality Assurance is Prilenia's primary quality lead for clinical development, owning GCP quality end-to-end from study start-up through inspection readiness, and serving as sponsor QA counterpart to our CRO(s) and Ferrer's QA team. The role also provides proportionate QA oversight for pharmacovigilance (GVP) and pre-clinical (GLP) activities. 

The ideal candidate is both a hands-on quality practitioner and a strategic partner to Clinical Development, Regulatory Affairs, Drug Safety, and Biostatistics, combining deep GCP/GvP/GLP expertise with the executive presence to influence cross-functional teams and senior leadership. 

Roles and Responsibilities:
GCP Quality - Core Focus
  • Ensure all Prilenia-sponsored trials are conducted, documented, and reported in compliance with applicable regulations, ICH guidelines, and Prilenia's SOPs.
  • Serve as Prilenia's day-to-day QA lead for Phase 3 clinical operations, embedded in the program team from protocol review through clinical study report sign-off.
  • Act as sponsor QA counterpart to CRO QA teams and to Ferrer's QA function, maintain quality oversight of outsourced trial execution, align on standards, and manage issue escalation.
  • Oversee eTMF quality, manage protocol deviations and GxP non-conformances, drive CAPA resolution with CROs and sites, and maintain continuous inspection readiness.
  • Lead inspection readiness and management for regulatory authority inspections (FDA, EMA, MHRA, PMDA); serve as primary QA contact, coordinate responses to observations, and oversee regulatory commitment closure.
  • Author and maintain GCP and related SOPs; define and track quality metrics and KPIs for senior leadership.
  • Oversee clinical site, CRO, and vendor audits; review reports, manage CAPA resolution; review and approve Quality Agreements.
QA Partnership & SME for GLP and GVP
  • Serve as GVP QA partner and SME to Drug Safety: oversee PV systems, vendor quality performance, and vendor audits; support CAPA resolution for safety findings; ensure compliance with EU GvP modules, FDA 21 CFR Part 312, and ICH E2 series.
  • Serve as GLP QA partner and SME for externally conducted pre-clinical studies; ensure compliance with OECD Principles of GLP and applicable national regulations.
QMS & Cross-Functional Leadership
  • Contribute to Prilenia's fit-for-purpose QMS, SOP lifecycle, quality event tracking, training, and regulatory intelligence.
  • Represent QA on clinical program teams and relevant governance forums.
  • Champion a proactive quality and compliance culture, making quality an enabler of clinical program success rather than a compliance exercise.
  • Mentor junior QA staff and foster professional development within the quality function.
Qualifications:
Required
  • Bachelor's degree or higher in life sciences, pharmacy, or a related discipline; advanced degree (MSc, PharmD) preferred.
  • Minimum 10 years of GCP QA experience within the pharmaceutical, biotechnology, or CRO industry, with at least 3 years in a leadership or director-level role at a biotech company.
  • Demonstrated expertise across GCP, GvP, and GLP quality frameworks; hands-on experience conducting and managing audits in all three domains.
  • Deep knowledge of ICH E6(R2/R3), ICH E2 series, FDA 21 CFR Parts 11/50/54/56/312, EU Clinical Trials Regulation (No. 536/2014), EU GvP modules, and OECD Principles of GLP.
  • Proven experience leading or managing regulatory authority inspections (FDA, EMA, MHRA, or equivalent) to successful outcomes.
  • Experience building or significantly maturing a QMS in a small-to-mid-size pharmaceutical setting.
  • Proficiency with eTMF systems (e.g., Veeva Vault, Wingspan) and electronic QMS platforms.
  • Exceptional communication skills; able to translate complex regulatory requirements into clear guidance for diverse audiences.
  • Highly autonomous, proactive, and resilient; comfortable in a fast-paced, resource-efficient environment.
Desirable
  • Experience in neurology, neurodegenerative disease, or rare disease clinical programs.
  • Familiarity with risk-based monitoring (RBM), centralized monitoring, and ICH E6(R3) risk-proportionate approaches.
  • Professional certification: RQAP-GCP (SQA), RAC (RAPS), CCRA (ACRP), or equivalent.
  • Experience supporting NDA/BLA/MAA submissions and post-approval quality oversight.
  • Knowledge of 21 CFR Part 11 / Annex 11 (computerized systems) and data integrity principles (ALCOA+).
Location/Time Zones:
  • This is a full-time remote position in the East Coast US, Israel or Europe.
  • Flexible schedule with frequent calls across Israel, North America and Europe time zones.
  • Occasional travel including internationally within US and Europe required.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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