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Gcp Qa Jobs in Raleigh, NC (NOW HIRING)

Cellectis

Director, Clinical Quality Assurance

Raleigh, NC · On-site

$190K - $2M/yr

The Director, Clinical Quality Assurance is primarily responsible for establishing and leading the ... Oversees GCP compliance for all clinical activities, including monitoring, data management, and ...

Cellectis

Director, Clinical Quality Assurance

Raleigh, NC · On-site

$190K - $2M/yr

The Director, Clinical Quality Assurance is primarily responsible for establishing and leading the ... Oversees GCP compliance for all clinical activities, including monitoring, data management, and ...

IQVIA

Senior QA Auditor - GCP Audits

Durham, NC · On-site

$75K - $188K/yr

Travel 30-50% * 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality * Assurance Audits. GCP experience. Equivalent combination of education, training and ...

IQVIA, Inc.

Senior QA Auditor - GCP Audits

Durham, NC · On-site

$75K - $188K/yr

Travel 30-50% * 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality * Assurance Audits. GCP experience. Equivalent combination of education, training and ...

Aerogen Ltd

Senior Director of Quality

Morrisville, NC · On-site

Will have oversight of clinical quality assurance (GCP). This position is a hybrid role, located in Morrisville, NC office and is a key member of the leadership team that contributes and supports the ...

Ruri Software Technologies LLC

Azure DevOps

Raleigh, NC · On-site

$49.25 - $67.50/hr

Collaborate with development, QA, and architecture teams to integrate DevOps best practices ... GCP) Soft Skills Strong problem-solving and analytical skills Excellent communication and cross ...

Luxoft

Senior Java Software Engineer

Cary, NC · On-site

$127K - $167K/yr

Team Challenges list includes both short and long term goals of introducing CI/CD process as well as BDD Automation QA, Environment adaptation to Cloud GCP technology migration by applying same ...

IQVIA

Clinical Project Lead, Oncology

Durham, NC · Remote

$68K - $232K/yr

... Quality Assurance * Coordinate ethics and regulatory submissions/approvals in collaboration with start-up teams * Ensure compliance with local regulations and global standards (ICH-GCP) What You ...

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All JobsGcp Qa JobsGcp Qa Jobs in Raleigh, NC

Gcp Qa information

See Raleigh, NC salary details

$36.9K

$114.8K

$174K

How much do gcp qa jobs pay per year?

As of Aug 6, 2026, the average yearly pay for gcp qa in Raleigh, NC is $114,777.00, according to ZipRecruiter salary data. Most workers in this role earn between $80,700.00 and $140,500.00 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 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 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 most commonly searched types of Gcp Qa jobs in Raleigh, NC? The most popular types of Gcp Qa jobs in Raleigh, NC are:
What are popular job titles related to Gcp Qa jobs in Raleigh, NC? For Gcp Qa jobs in Raleigh, NC, the most frequently searched job titles are:
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Gcp Qa jobs near you
Infographic showing various Gcp Qa job openings in Raleigh, NC as of August 2026, with employment types broken down into 1% As Needed, 87% Full Time, 3% Part Time, 8% Contract, and 1% Nights. Highlights an 89% Physical, 3% Hybrid, and 8% Remote job distribution, with an average salary of $114,777 per year, or $55.2 per hour.

Director, Clinical Quality Assurance

Cellectis

Raleigh, NC • On-site

$190K - $2M/yr

Full-time

Re-posted 28 days ago

Job description


The Director, Clinical Quality Assurance is primarily responsible for establishing and leading the Clinical QA function and providing independent oversight of Good Clinical Practices (GCP) activities to ensure compliance with FDA, EMA, ICH, and other applicable global and national regulatory requirements across Cellectis' clinical programs. This role provides strategic and operational quality leadership in alignment with other departments and company goals. They develop and implement a comprehensive Clinical Quality Assurance framework that safeguards patient safety, data integrity, and regulatory compliance throughout the clinical development lifecycle. The Director, Clinical Quality Assurance, will manage activities and projects based on short-term and long-term company goals. This position is also part of the Global Cellectis Quality Leadership team actively contributing to the overall global Quality strategy and initiatives.
Position Responsibilities
  • Defines and executes the Clinical QA strategy throughout the development trajectory including early-phase and late stage clinical development
  • Oversees GCP compliance for all clinical activities, including monitoring, data management, and pharmacovigilance
  • Develop and implement inspection readiness plans and procedures ensuring that clinical studies and related activities are ready for Health Authority inspections
  • Direct risk-based quality planning and continuous improvement initiatives across clinical programs
  • Manage vendor qualifications, audits, and corrective/preventive actions (CAPAs)
  • Collaborate cross-functionally to integrate quality principles into clinical development and regulatory deliverables
  • Provide training and guidance to cross-functional teams on GCP regulations, Quality Assurance procedures, and audit protocols
  • Develops quality strategies and priorities for short- and long-term objectives for the QA organization.
  • In collaboration with internal stakeholders, ensure risk-based quality management is applied as appropriate to specific studies
  • Facilitate review of potential Serious Breach and Urgent Safety Measure assessments arising from clinical program
  • Plan, coordinate, review, and approve clinical audits using risk-informed strategy to ensure compliance in clinical studies and pharmacovigilance operations
  • Implement and run internal GCP audit and training programs
  • Serve as a subject matter expert on GCP quality assurance matters
  • Develop KPIs to track and trend key Quality Indicators and ensures that any adverse trends or patterns are noted and are promptly addressed
  • Travel up to 10% of the time
  • Such other responsibilities and duties as the Company may from time-to-time assign

Education and Experience
  • Bachelor's or master's degree in science preferably in a Life Science, with at least twelve (12) years of relevant GCP, PV, and QA experience in a biopharmaceutical company. 8+ years of direct supervisory experience.
  • Extensive clinical trial experience in biological therapies and in oncology, ideally in CAR-T therapies and hemato-oncology.
  • Experience supporting IND, CTA, and BLA/MAA or other regulatory submissions.

Technical Skills / Core Competencies
  • Demonstrated ability to identify critical program risks and develop plans, strategic or tactical, to mitigate risks and costs. Knowledge and understanding of regulations regarding cell/gene therapies including but not limited to ICH guideline, GCP, and GMP as defined by the US Food and Drug Administration and European Medicines Agency.
  • Comprehensive knowledge of cell and gene therapy, GxPs, and the theories and general principles behind them.
  • Comprehensive knowledge of compliance with GCP worldwide regulations. Strong project management skills.
  • Demonstrated ability to lead, motivate, and influence a strategic direction. Ability to effectively leverage and develop diverse perspectives and ideas from matrix teams.
  • Ability to independently lead initiatives, assess complex challenges, and implement practical solutions.
  • Strong written and verbal communication skills. Bilingual in French and English preferred.
  • Ability to set and manage priorities and schedule activities accordingly. Strong analytical and problem-solving skills.
  • Demonstrated interpersonal skills to work effectively with subordinates, peers, managers, and cross-functional teams.
  • Excellent organizational skills with attention to detail and deadlines.
  • Strong team orientation including the ability to coach and mentor.

Anticipated Compensation Range: $190,000 - $234,0000

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