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Gcp Qa Jobs (NOW HIRING)

Acadia Pharmaceuticals Inc.

$165K - $207K/yr

Position Summary The Director, GCP Quality Assurance is responsible for leading Good Clinical Practice (GCP) audit activities across Acadia's clinical development portfolio to ensure compliance with ...

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 ...

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 ...

Shionogi Inc.

Senior Manager, GCP QA

Florham Park, NJ · On-site

$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 · On-site

$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 ...

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How much do gcp qa jobs pay per year?

As of Sep 10, 2026, the average yearly pay for gcp qa 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 QA?

A GCP QA (Good Clinical Practice Quality Assurance) job involves ensuring compliance with regulatory guidelines in clinical research. Professionals in this role conduct audits, review protocols, and ensure clinical trials adhere to industry standards such as FDA and ICH guidelines. They work to identify, report, and mitigate risks to maintain the integrity of clinical data. GCP QA specialists collaborate with regulatory agencies, clinical teams, and sponsors to ensure ethical and quality-driven research practices.

What are the typical responsibilities of a GCP QA throughout a clinical trial?

GCP QA professionals are responsible for planning, conducting, and documenting quality audits of clinical trial processes, ensuring compliance with Good Clinical Practice guidelines and regulatory requirements. They review study documentation, identify compliance gaps, and work closely with clinical project teams to implement corrective actions. GCP QA specialists regularly communicate with sponsors, investigators, and regulatory agencies. Their oversight ensures data integrity and subject safety throughout the clinical trial lifecycle, which is vital for successfully bringing new therapies to market.

What are the key skills and qualifications needed to thrive in the GCP QA position, and why are they important?

To thrive as a GCP QA, you need a strong understanding of Good Clinical Practice (GCP) guidelines, clinical research processes, and quality assurance methodologies, often backed by a degree in life sciences or a related field. Experience with audit tools, electronic data capture (EDC), and certifications such as RQAP-GCP or similar are highly advantageous. Excellent attention to detail, communication skills, and the ability to work collaboratively stand out as essential soft skills. These capabilities ensure compliance, data integrity, and the smooth execution of clinical trials within regulatory frameworks.

What cities are hiring for Gcp Qa jobs?

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

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Gcp Qa jobs near you
Infographic showing various Gcp Qa job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 88% Full Time, 4% Part Time, 5% Contract, and 1% Nights. Highlights an 86% Physical, 4% Hybrid, and 10% Remote job distribution, with an average salary of $118,074 per year, or $56.8 per hour.

Director, GCP Quality Assurance

San Diego, CA • On-site

Scorpion Therapeutics
51 - 200 employees
Learn more about Scorpion Therapeuticsexternal

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 2 days ago

New

Job description

Position Summary

The Director, GCP Quality Assurance leads Good Clinical Practice (GCP) audit activities across the clinical development portfolio to ensure compliance with global regulatory requirements and internal quality standards. Provides strategic oversight of GCP quality systems, manages audit programs, supports inspection readiness, and serves as a GCP compliance subject matter expert.

Primary Responsibilities
  • Plan, schedule, conduct, and manage internal/external GCP audits of CSPs, CROs, investigator sites, and vendors
  • Prepare/review/finalize audit reports; document observations, risks, and corrective actions; track to resolution
  • Develop/review/maintain GCP Quality Agreements with CROs, CSPs, and clinical study partners
  • Maintain GCP audit metrics and deliver quality/compliance reporting for management reviews and continuous improvement
  • Develop/review/maintain SOPs and quality documents supporting GCP auditing and compliance
  • Manage internal GCP audit program (planning, execution, follow-up, and effectiveness assessments)
  • Support mock and regulatory inspections and responses for GCP studies/quality systems
  • Provide GCP compliance guidance to cross-functional stakeholders to ensure adherence to FDA, ICH, EU, and other global requirements
  • Recommend and implement improvements to GCP quality systems, processes, and procedures
Education & Experience (Required)
  • Bachelor’s in Life Sciences or related field (or equivalent education/experience)
  • 10+ years in pharmaceutical/biotech/regulated industry
  • 5+ years in GCP Quality Assurance, compliance, and auditing
  • Lead Auditor experience for internal/external GCP audits
  • Strong knowledge of ICH-GCP and applicable FDA/EU/international GCP regulations
  • Audit experience covering CROs, investigator sites, and GCP service providers
  • Experience supporting regulatory inspections/inspection readiness
Preferred Qualifications
  • SQA/ASQ/Lead Auditor certification
  • Experience conducting global audits across US/EU/UK/Japan and other regions
  • Experience with eCOA, CSV, and data management
Benefits (as stated)
  • Medical, dental, vision; 401(k) match 1:1 up to 5%; equity; bonus; life/disability/EAP; tuition assistance; paid time off; paid parental leave; sick time.
Physical/Other
  • Ability to travel overnight independently and work after hours if required.
  • Occasionally lift/move up to 15 pounds.
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