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Gcp Qa Manager Jobs (NOW HIRING)

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 ... Proven leadership, communication, relationship-building, and ability to manage complex/multiple ...

Alkira

QA Manager

San Jose, CA

... Azure, GCP, OCI). Beyond release validation, the team builds scaling and performance tests that ... We are looking for a QA Manager to lead our QA & Automation team and help ensure the quality ...

Alkira, Inc.

QA Manager

San Jose, CA · On-site

... Azure, GCP, OCI). Beyond release validation, the team builds scaling and performance tests that ... We are looking for a QA Manager to lead our QA & Automation team and help ensure the quality ...

Integrated Resources INC

QA Manager

East Windsor, NJ · On-site

Ensure all GMP, GLP, GCP operations are in compliance , Establish training and audit programs, as ... Be responsible for release or rejection of GMP materials and utilize QA staff to manage the ...

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Gcp Qa Manager information

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How much do gcp qa manager jobs pay per year?

As of Sep 14, 2026, the average yearly pay for gcp qa manager in the United States is $86,159.00, according to ZipRecruiter salary data. Most workers in this role earn between $44,000.00 and $136,000.00 per year, depending on experience, location, and employer.

What is the difference between Gcp Qa Manager vs Gcp Quality Analyst?

AspectGcp Qa ManagerGcp Quality Analyst
CertificationsGCP certifications, QA certificationsGCP certifications, QA certifications
Work EnvironmentTeam leadership, project managementTesting, analysis, reporting
ResponsibilitiesOversees QA teams, develops testing strategiesPerforms testing, identifies defects

The Gcp Qa Manager focuses on leading QA teams and managing testing projects, while the Gcp Quality Analyst handles hands-on testing and defect identification. The manager role involves strategic planning and team coordination, whereas the analyst role emphasizes technical testing skills. Both roles require similar certifications and are integral to quality assurance in GCP environments.

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

The most popular types of Gcp Qa jobs are:

What are popular job titles related to Gcp Qa Manager jobs?

For Gcp Qa Manager jobs, the most frequently searched job titles are:

Infographic showing various Gcp Qa Manager job openings in the United States as of September 2026, with employment types broken down into 87% Full Time, 12% Part Time, and 1% Contract. Highlights an 79% Physical, 2% Hybrid, and 19% Remote job distribution, with an average salary of $86,159 per year, or $41.4 per hour.

Sr. Director, Head of Clinical Quality Assurance

Cambridge, MA • On-site

Scholar Rock
Biotechnology Research and Development • 51 - 200 employees
Learn more about Scholar Rockexternal

Full-time

Posted 19 days ago

Job description

Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
 
Summary of Position:

Scholar Rock is seeking an experienced and motivated Senior Director, Head of Clinical Quality Assurance to provide strategic and operational leadership for Good Clinical Practice (GCP) quality across the company's biologics clinical development portfolio. Reporting to the Head of Global Quality, this role will serve as the senior Clinical QA leader and trusted partner to Clinical Operations, Clinical Development, Regulatory Affairs, Pharmacovigilance, Biometrics, Data Management, and external clinical service providers. The position is accountable for clinical quality strategy, GCP quality systems, clinical quality risk management, CRO and vendor oversight, audit strategy, inspection readiness, quality metrics, and the maturation of fit-for-purpose processes that embed quality by design across the clinical trial lifecycle.

Position Responsibilities:
  • Lead the Clinical Quality Assurance function, providing strategic direction and operational oversight for GCP quality across Scholar Rock-sponsored clinical trials, with a focus on biologics development programs.
  • Serve as the senior GCP Quality partner to Clinical Operations, Clinical Development, Regulatory Affairs, Pharmacovigilance, Biometrics, Data Management, and other cross-functional stakeholders.
  • Define, implement, and continuously mature the clinical quality strategy, governance model, and GCP quality management processes aligned with global regulatory expectations and clinical development priorities.
  • Provide quality oversight for global clinical trials, including protocol compliance, informed consent processes, investigator site oversight, trial master file quality, data integrity, safety reporting interfaces, and clinical study documentation.
  • Establish and execute a risk-based GCP audit program, including audits of investigator sites, CROs, vendors, clinical systems, TMF processes, and key internal clinical trial activities.
  • Lead GCP inspection readiness activities and support preparation, conduct, response development, and follow-up for FDA, EMA, PMDA, and other health authority inspections.
  • Provide oversight of GCP deviations, serious breaches, audit observations, inspection findings, CAPAs, and quality issues to ensure timely investigation, appropriate root cause analysis, effective corrective actions, and sustainable remediation.
  • Oversee CRO and clinical vendor quality governance, including qualification, risk assessment, quality agreements where applicable, performance metrics, issue escalation, and continuous improvement.
  • Partner with clinical and regulatory teams to proactively identify and mitigate quality risks associated with study design, trial execution, vendor performance, data integrity, patient safety, protocol deviations, and submission readiness.
  • Develop and monitor GCP quality metrics, dashboards, and trend reports to support proactive risk management, governance discussions, and executive-level quality visibility.
  • Author, review, and approve GCP-related SOPs, policies, quality plans, audit reports, CAPA plans, inspection materials, and other controlled documents as appropriate.
  • Build, lead, and develop a fit-for-purpose Clinical QA function appropriate for a fast-paced, outsourced biotech operating model.
  • Champion a culture of quality, accountability, patient safety, data integrity, transparency, and continuous improvement across internal teams and external partners.
Candidate Requirements:
  • BS/MS degree in a scientific, healthcare, or related discipline; advanced degree preferred.
  • 15+ years of experience in the pharmaceutical/biotech industry, including significant experience in Clinical Quality Assurance, Clinical Operations, clinical development, or related GCP compliance roles.
  • 10+ years of hands-on GCP quality experience, including leadership of global clinical quality programs and oversight of Phase I-III clinical trials.
  • Deep knowledge of ICH-GCP, ICH E6(R3), FDA, EMA, PMDA, and other global clinical trial regulations and expectations.
  • Experience supporting biologics clinical development programs; late-stage development, registration-enabling studies, and inspection readiness experience strongly preferred.
  • Demonstrated experience leading or supporting regulatory inspections, including inspection preparation, hosting, response development, CAPA management, and follow-up commitments.
  • Strong experience with CRO and clinical vendor oversight, investigator site audits, TMF quality, clinical systems, data integrity, risk-based quality management, and quality issue escalation.
  • Proven ability to design and mature fit-for-purpose GCP quality systems, SOPs, audit programs, quality metrics, governance forums, and inspection readiness frameworks in an outsourced biotech model.
  • Strong judgment, executive presence, technical writing capability, and the ability to influence cross-functional leaders and external partners.
  • Highly proactive, decisive, and capable of balancing strategic leadership with hands-on execution in a fast-paced environment.
  • Engaged leader committed to building culture, mentoring talent, and developing scalable Clinical QA capabilities.
$270,000 - $300,000 a year
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. 
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