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AskBio

Sr. Quality Assurance Specialist

Durham, NC · On-site

$79K - $109K/yr

This position will work closely with the GCP/GLP/GCLP QA and SMEs. This position will be office-based in RTP, NC and will report to the Senior Director, QA - Product Quality. Job Responsibilities

AskBio

Sr. Quality Assurance Specialist

Durham, NC

$79K - $109K/yr

This position will work closely with the GCP/GLP/GCLP QA and SMEs. This position will be office-based in RTP, NC and will report to the Senior Director, QA - Product Quality. Job Responsibilities

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How much do gclp jobs pay per hour?

As of Jun 6, 2026, the average hourly pay for gclp in the United States is $24.06, according to ZipRecruiter salary data. Most workers in this role earn between $16.83 and $25.96 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Good Clinical Laboratory Practice (GCLP) professional, and why are they important?

To thrive as a GCLP professional, you need a solid background in clinical laboratory sciences, regulatory compliance, and quality management, often supported by relevant degrees or certifications in laboratory practices. Familiarity with laboratory information management systems (LIMS), GCLP guidelines, and audit procedures is typically required. Attention to detail, strong organizational abilities, and effective communication are important soft skills for success in this role. These competencies ensure the accuracy, reliability, and regulatory compliance of laboratory data in clinical trials, which are critical for patient safety and valid research outcomes.

What is the difference between Gclp vs Clinical Laboratory Scientist?

AspectGclpClinical Laboratory Scientist
CertificationsGCLP certification, Good Clinical Laboratory PracticeASCP certification, CLS license
Work EnvironmentClinical research labs, pharmaceutical settingsHospital labs, diagnostic labs
Industry UsagePharmaceuticals, clinical researchHealthcare, diagnostics

Gclp professionals focus on ensuring compliance with Good Clinical Laboratory Practice in research settings, while Clinical Laboratory Scientists perform diagnostic testing in healthcare labs. Both roles require laboratory skills but differ in industry focus and certifications.

What job makes $10,000 a month without a degree?

A GCLP (Good Clinical Laboratory Practice) professional in the biotech or pharmaceutical industry can potentially earn $10,000 or more per month through roles such as senior laboratory managers or clinical research coordinators, especially with extensive experience and certifications. These positions often require specialized knowledge of laboratory standards, regulatory compliance, and strong technical skills, but may not require a traditional college degree.

What are GCLP professionals?

GCLP professionals are individuals who work in compliance with Good Clinical Laboratory Practice (GCLP) standards. These standards ensure the quality, reliability, and integrity of laboratory data generated in clinical trials. GCLP professionals are responsible for overseeing laboratory operations, maintaining documentation, ensuring regulatory compliance, and supporting clinical research activities. Their work is critical in providing accurate laboratory results that support drug development and patient safety.

What are some common challenges faced by professionals working in a GCLP (Good Clinical Laboratory Practice) role, and how can they be addressed?

Professionals in a GCLP role often encounter challenges such as maintaining stringent compliance with regulatory standards, managing documentation accurately, and ensuring effective communication between laboratory and clinical teams. Adapting to evolving guidelines and integrating new technologies can also present difficulties. Addressing these challenges involves ongoing training, robust quality management systems, and fostering a culture of open collaboration, which helps ensure data integrity and smooth workflow in clinical research settings.
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Infographic showing various Gclp job openings in the United States as of May 2026, with employment types broken down into 98% Full Time, 1% Part Time, and 1% Contract. Highlights an 87% Physical, 3% Hybrid, and 10% Remote job distribution, with an average salary of $50,049 per year, or $24.1 per hour.
Director, Quality (GCP/GCLP/GVP)

Director, Quality (GCP/GCLP/GVP)

Larimar Therapeutics

Bala Cynwyd, PA • On-site

Other

Retirement, PTO

Posted 11 days ago

Job description

Description

The Company:

Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. 

The company assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices.

The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.


Position:

Director, Quality (GCP/GCLP/GVP)

Reports to: Sr. Director, Quality


Job Responsibilities:


Position Overview:

The Director, Quality (GCP/GCLP/GVP) will play a key role in shaping and strengthening Larimar's Quality Management System and advancing quality oversight across clinical product development and clinical studies. In this highly visible role, the candidate will collaborate cross-functionally to proactively manage GCP/GCLP/GVP regulatory risks, support inspection readiness, and continuously improve quality standards utilizing insights from inspections, audits, and evolving regulatory landscapes. This position will also assist with management of internal quality systems and processes while ensuring compliance with Larimar requirements and relevant global GCP, GCLP and GVP regulations and guidelines. The Director, Quality (GCP/GCLP/GVP) works with all members of the Quality team, including relevant internal contractors, to ensure quality compliance internally and among the company's contractors, CROs, service providers, etc. to enable development, regulatory approval, and commercialization of the company's products. This role reports to the Sr. Director, Quality.


Key Responsibilities:

Will include but are not limited to:

  • Develops, implements, and executes the risk-based audit strategy for Clinical and Pharmacovigilance programs.
  • Oversees/leads the execution and completion of external audits of GCP/GCLP/GVP vendors and clinical trial sites, including collaboration with the business sponsors to share audit findings.
  • Leads internal GCP/GCLP/GVP audits.
  • Collaborates with Quality representatives at Larimar's CROs and service providers to ensure the appropriate Quality Agreements have been developed and implemented in support of Larimar's clinical studies.
  • Develops and monitors Larimar's Risk Management Program for clinical studies.
  • Ensures reporting of potential or confirmed violations to regulatory authorities, as appropriate.
  • Provides Good Clinical Practices (GCP) guidance and training to internal teams 
  • Manages evaluation of new GCP/GCLP/GVP related regulations and potential implications for Larimar.
  • Supports the development and/or revision of Quality, Clinical, and Pharmacovigilance processes and procedures including SOPs and risk assessment tools ensuring consistency and compliance with relevant GCP, GCLP, CLIA, FDA, EMA, and other global regulatory requirements.
  • Directly supports inspection readiness preparation (core team) and supports regulatory agency inspection(s). 
  • Assists in compiling information for regulatory submissions and conducting quality reviews and auditing of regulatory submissions, as requested.
  • Supports quality system monitoring reviews.
  • Supports other Quality activities, as required.
  • Approximately 15-20% travel required

Requirements

Qualifications:

  • Bachelor's degree in life sciences with a minimum of 10+ years experience in a Quality role supporting Clinical Operations and/or Pharmacovigilance departments within a biotechnology or pharmaceutical environment 
  • Experience managing GCP/GCLP/GVP quality processes, including risk management activities 
  • Demonstrated experience managing GCP inspections, including preparation and response activities
  • Minimum of 3 years experience performing GCP/GCLP/GVP audits or comparable GxP audit experience
  • Expert knowledge of GxP systems, quality principles, and GCP/GCLP/GVP regulations (FDA, MHRA, EMA, etc.) and guidance documents (GCP/ICH) and ability to translate understanding to practice 
  • Demonstrated ability to initiate process improvements and take initiative is required
  • Must possess a strong attention to detail while having the ability to work independently and collaboratively, as required, in a fast-paced environment 

Benefits:


Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.


We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.

Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the  relationship with all candidates and  employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.

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