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Ich Gcp Jobs (NOW HIRING)

ImmunityBio, Inc.

Senior GCP Auditor

$82K - $101K/yr

Ensures compliance with SOPs and ICH GCP E6 (R2) standards. * Manages the incident management program through monitoring of complaints, deviations and CAPAs. * Schedules, plans, coordinates, and ...

Shionogi Inc.

Senior Manager, GCP QA

Florham Park, NJ · On-site

$135K - $165K/yr

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 ...

Shionogi Inc.

Senior Manager, GCP QA

Florham Park, NJ · On-site

$135K - $165K/yr

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 ...

Shionogi Inc.

Senior Manager, GCP QA

Florham Park, NJ

$135K - $165K/yr

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 ...

Madrigal Pharmaceuticals

Align organization to ICH in implementing a quality culture from the outset of clinical trials to ... Demonstrated GCP knowledge; GVP/GLP knowledge or certifications a plus * BS in a scientific or ...

CEDENT

Study Start-Up Manager

Wilmington, DE

This role requires a strong background in regulatory processes, site management, and expertise in ensuring compliance with local and international guidelines, particularly ICH-GCP. Key ...

Vrtx

GCP Operational Quality Senior Manager

Boston, MA · On-site

$137K - $206K/yr

In-depth knowledge of ICH GCP R2 and applicable global regulations and guidance for clinical development (e.g., FDA regulations, EU Regulations and Directives, MHRA Statutory Instruments, etc.

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Ich Gcp information

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$49.5K

$116.3K

$176K

How much do ich gcp jobs pay per year?

As of Aug 7, 2026, the average yearly pay for ich gcp in the United States is $116,307.00, according to ZipRecruiter salary data. Most workers in this role earn between $85,000.00 and $143,500.00 per year, depending on experience, location, and employer.

How to become ICH GCP certified?

To become ICH GCP certified, individuals typically complete a recognized GCP training course that covers clinical trial regulations, ethical standards, and Good Clinical Practice guidelines. After training, some certifications require passing an exam to demonstrate understanding of GCP principles, which are essential for roles in clinical research and trial management.

What are the key skills and qualifications needed to thrive as an ICH GCP professional?

To thrive as an ICH GCP professional, you need a solid understanding of clinical research principles, regulatory compliance, and the ethical conduct of clinical trials, typically supported by relevant life sciences degrees and GCP certification. Familiarity with electronic data capture (EDC) systems, clinical trial management systems (CTMS), and regulatory documentation platforms is essential. Attention to detail, strong communication, and organizational skills help ensure protocol adherence and effective teamwork. These competencies are critical for safeguarding participant safety, ensuring data integrity, and meeting regulatory standards in clinical research.

What are some common challenges faced by professionals working in ICH GCP roles, and how can they be addressed?

Professionals in ICH GCP roles often encounter challenges such as ensuring strict regulatory compliance, managing complex documentation, and maintaining clear communication across multi-disciplinary clinical trial teams. Staying updated with evolving global regulations and standards can also be demanding. To address these challenges, it's important to participate in ongoing training, leverage robust project management tools, and foster open lines of communication among stakeholders. Building strong relationships with site staff and regulatory authorities further supports smooth trial operations.

What is the difference between Ich Gcp vs Cloud Engineer?

AspectIch GcpCloud Engineer
CertificationsGoogle Cloud certifications (e.g., Associate Cloud Engineer, Professional Cloud Architect)Various cloud certifications (AWS, Azure, Google Cloud)
Work EnvironmentPrimarily in Google Cloud environments, focusing on GCP tools and servicesIn diverse cloud platforms, including AWS, Azure, and GCP, depending on employer
Industry UsageUsed in companies leveraging Google Cloud Platform for their infrastructureCommon across multiple industries adopting cloud solutions
Job FocusImplementing, managing, and optimizing GCP servicesDesigning, deploying, and maintaining cloud infrastructure across platforms

While both roles involve cloud technology, Ich Gcp specializes in Google Cloud Platform services, whereas a Cloud Engineer may work across multiple cloud providers. The choice depends on the company's cloud strategy and required certifications.

What are ICH GCP guidelines?

ICH GCP, or International Council for Harmonisation Good Clinical Practice, are ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials involving human subjects. These guidelines ensure that the rights, safety, and well-being of trial participants are protected and that clinical trial data are credible and accurate. ICH GCP is widely accepted internationally and is required by regulatory authorities in many countries for clinical research. Adhering to these guidelines is crucial for anyone involved in clinical trials.
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Ich Gcp jobs near you
Infographic showing various Ich Gcp job openings in the United States as of August 2026, with employment types broken down into 87% Full Time, and 13% Contract. Highlights an 87% In-person, and 13% Hybrid job distribution, with an average salary of $116,307 per year, or $55.9 per hour.

Quality Assurance Manager - GCP

Cognitive Research Corporation

Remote

Full-time

Posted 3 days ago

New

Job description

The Quality Assurance (QA) Manager plays a critical role in overseeing and executing Clinical Quality Assurance activities that uphold and enhance the organization's Quality Management System (QMS). Reporting to Quality Assurance Leadership, this position ensures compliance with ICH GCP, applicable global regulations, and internal quality standards, while fostering a culture of continuous improvement.
The QA Manager leads key quality functions, including audits, quality event management, vendor qualification, training, and risk-based quality planning. This role partners cross-functionally with clinical operations, vendors, sponsors, and leadership to maintain operational excellence and ensure that clinical research activities meet both regulatory and sponsor expectations.
Essential Duties and Responsibilities:
Quality Assurance Operations
  • Manage and monitor clinical QA activities, ensuring compliance with QMS, ICH GCP, and regulatory requirements.
  • Execute day-to-day QA operations to support the QMS while meeting business goals and sponsor requirements.
  • Foster a quality-focused culture, promoting awareness and driving continuous improvement initiatives across clinical programs.
  • Maintain current knowledge of industry best practices, quality trends and evolving regulations, integrating insights into QA decision-making.

Quality Management System (QMS) & Documentation
  • Develop, author, review, and maintain QMS documentation, including SOPs, Work Instructions, Templates, and Forms.
  • Support Quality Management Review (QMR) activities, including data analysis, reporting, and tracking action items to completion.

Quality Events & CAPA Management
  • Oversee the management of Quality Events and CAPAs, ensuring timely investigation, root cause analysis, effectiveness checks, and closure.
  • Review and assess clinical site and vendor Quality Events, ensuring appropriate resolution and compliant documentation.
  • Evaluate CAPA plans for adequacy, regulatory alignment, and operational feasibility.

Audits & Inspection Readiness
  • Lead or support the planning, conduct, and documentation of internal, vendor, and clinical site audits, including detailed reporting and CAPA tracking.
  • Lead or support sponsor audits and regulatory inspection readiness, including preparation, hosting, and follow-up activities.
  • Author and review audit responses, ensuring timely, accurate, and effective resolution of findings.

Vendor Qualification & Oversight
  • Lead or support vendor qualification and requalification, including risk-based assessments, audits, and ongoing compliance monitoring.

Risk-Based Quality Management
  • Apply a risk-based approach to support the planning, prioritization, and execution of quality initiatives.
  • Identify, assess, and mitigate quality and compliance risks across clinical studies and operational areas.

Quality Metrics & Continuous Improvement
  • Analyze quality data and metrics, including audit trends, Quality Events, and CAPA outcomes, to identify patterns and drive process improvements.
  • Provide regular reports to senior leadership on quality trends, risks, and mitigation strategies.

Cross-Functional Collaboration
  • Collaborate with clinical operations, medical, regulatory, and vendor teams to ensure alignment on quality expectations and risk management.
  • Provide QA consultation for controlled document development, process optimization, and clinical trial execution.

Business Development & Sponsor Support
  • Assist with sponsor RFIs, due diligence questionnaires, and quality agreements, ensuring timely and accurate responses.
  • Serve as a QA representative in sponsor meetings, fostering strong sponsor relationships and transparent quality communications
  • Perform other duties as assigned by management.

Qualifications:
Education & Experience
  • BS/BA/MS in Life Sciences, Pharmacy, Nursing, or a related field, or equivalent combination of education and experience; advanced degree (e.g., MS, MPH) preferred.
  • 5-10 years of GCP Quality Assurance experience, preferably in a CRO environment.

Knowledge & Skills
  • Deep knowledge of ICH GCP, FDA and other global regulatory guidelines.
  • Experience in authoring, reviewing, and managing QMS documents and quality records.
  • Excellent written, verbal, and presentation skills, with the ability to communicate complex concepts clearly.
  • Demonstrated ability to collaborate in cross-functional teams, with a proactive and solution-oriented approach.
  • Strong organizational, time management, and prioritization skills; able to manage multiple projects in a fast-paced, matrixed environment.
  • Analytical and risk-based thinking, with the ability to interpret quality metrics and drive continuous improvement.
  • Effective in influencing, negotiating, and implementing effective quality solutions.
  • Meticulous attention to detail with auditing and investigative skills.
  • Proficient in Microsoft Office, QMS systems, and electronic Trial Master File (eTMF) platforms.
  • Ability to handle sensitive and confidential information with discretion and integrity.
  • Ability to travel <10%.

Department QA Role Quality Assurance Manager Locations Remote, US Remote status Fully Remote Employment type Full-time

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