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Commission Gcp Qa Jobs (NOW HIRING)

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 ...

Madrigal Pharmaceuticals

Rezdiffra is the first and only medication approved by both the FDA and European Commission for the ... Position Summary This position will be responsible for GCP/Clinical Quality Assurance activities.

Scorpion Therapeutics

Director, Clinical QA

San Diego, CA · On-site

$181K - $248K/yr

Lead GCP QA vision, goals, capabilities, and quality culture. * Provide quality guidance and interpretation of GCP requirements with Clinical Development, Clinical Operations, Biostatistics ...

Sobi

QA Manager, GCP

Raleigh, NC

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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How much do commission gcp qa jobs pay per hour?

As of Sep 12, 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.

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Commission Gcp Qa jobs near you
Infographic showing various Commission Gcp Qa job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 83% Full Time, 9% Part Time, and 7% Contract. Highlights an 71% Physical, 1% Hybrid, and 28% Remote job distribution, with an average salary of $97,144 per year, or $46.7 per hour.

Senior Manager, GCP QA

Florham Park, NJ • On-site

Shionogi Inc.
Pharmaceutical and Medicine Manufacturing • 201 - 500 employees
Learn more about Shionogi Inc.external

$135K - $165K/yr

Other

Re-posted 27 days ago

Job description

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 with ICH GCP and FDA regulatory requirements, and upholding our high standards for data integrity. The ideal candidate will provide advisory and collaborate with clinical study teams and internal departments to assess and mitigate risks associated with vendors.
Responsibilities
Quality Oversight for Clinical Studies and Vendor Oversight Program:
  • Provide quality oversight and GCP guidance to clinical study teams and CROs/vendors to ensure compliance with ICH GCP and FDA regulatory requirements, as well as Shionogi standards.
  • Ensure clinical trials adhere to GCP principles, producing high-quality and reliable data.
  • Evaluate clinical trial documentation, processes, and study plans to ensure alignment with Shionogi's expectations and regulatory requirements.
  • Interpret and evaluate clinical and regulatory compliance requirements in coordination with the GCP QA team to meet company obligations.
  • Collaborate with clinical study teams to provide vendor quality oversight, identify risks, and propose remediation actions. Conduct CRO or vendor audits or assessments.
  • Develop, as needed, and ensure the GCP audit plan(s) is(are) executed for assigned clinical studies as part of quality oversight. Conduct investigator site audits or TMF audits.
  • Work with internal cross-functional teams to assess risks associated with vendors and implement risk mitigation strategies to ensure product quality, study compliance, data integrity, and patient safety.

General Quality and Regulatory Compliance:
  • Maintain up-to-date knowledge of applicable regulations, industry standards, and Shionogi GCP standards and their interpretations.
  • Provide guidance on quality and compliance issues, ensuring adherence to applicable regulations, guidelines, and company policies.
  • Evaluate the effectiveness of CAPAs and follow up on audit findings to ensure timely resolution.

Audit Support:
  • Perform GCP audits (e.g., CRO, vendor, investigator site, TMF, internal process) and manage the GCP audit process for self-performed audits and outsourced audits.
  • Support GCP regulatory inspections and manage assigned CAPAs identified during inspections.
  • Other duties as assigned.
Minimum Job Requirements
Qualifications:
  • BA/BS in life sciences, a scientific, technical discipline, or a related field.
  • Minimum of 5 years of experience in a GCP QA/quality/compliance role supporting clinical study teams.
  • Working knowledge of GCP regulations and guidelines, including ICH, FDA, EMA, and PMDA requirements.
  • Experience in performing GCP-related audits.

Competencies:
  • Strong attention to detail, team player, agile, excellent communication skills, strong critical thinking skills, and effective problem-solving abilities.
  • Experience with various types of clinical trials and familiarity with additional regulatory environments.
  • Capable of operating in an ambiguous environment.
  • Capable of operating independently with a leveled understanding of decision making.

Other Requirements:
  • Ability and willingness to travel up to 25% of the year both domestically and internationally.
  • Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month.

Additional Information
The base salary range for this full-time position is $135,000 - $165,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role
EEO
Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.
If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.
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About Shionogi

Sourced by ZipRecruiter

Industry

Pharmaceutical and medicine manufacturing

Company size

201 - 500 Employees

Headquarters location

Florham Park, NJ, US

Year founded

2001

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