Director, Clinical Quality Assurance jobs in United States
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Solid Biosciences · 17 hours ago

Director, Clinical Quality Assurance

positionUnited States
timeFull-time
remoteRemote
seniorityLead/Staff, Director/Executive
money$197K/yr - $234K/yr
date5+ years exp

Solid Biosciences is a precision genetic medicine company focused on advancing gene therapy candidates for rare diseases. The Clinical Quality Assurance Director is responsible for establishing and maintaining quality systems to ensure compliance with regulatory requirements and best practices in clinical trials.

BiotechnologyGeneticsHealth CareMedical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Develop, implement, and maintain the Clinical Quality Management System (CQMS) to support inspection readiness and regulatory compliance
Provide GCP compliance oversight to all clinical programs, including CROs, clinical sites, vendors, and internal teams
Review clinical documentation (protocols, monitoring plans, TMF, vendor deliverables, etc.) to ensure compliance and quality
Serve as a subject matter expert (SME) for GCP and clinical quality best practices
Plan, execute, and report on internal and external audits (e.g., sites, vendors, TMF, system audits)
Track and support resolution of audit findings and CAPAs
Lead preparation for regulatory inspections (FDA, EMA, MHRA, etc.)
Facilitate mock inspections, training, and inspection logistics
Lead clinical risk assessments using quality-by-design (QbD) and risk-based quality management (RBQM) principles
Identify systemic risks across the clinical trial portfolio and implement risk mitigation strategies
Monitor key quality indicators (KQIs), KPIs, deviations, and other signals to detect emerging risks
Partner with Clinical Operations and Data Management to evaluate and escalate risks proactively
Evaluate and qualify CROs and key service providers from a quality perspective
Perform vendor audits when needed and oversee vendor risk assessments
Partner with Clinical Operations to ensure oversight plans are robust and followed
Conduct GCP and quality training for clinical staff, CROs, and investigators
Develop and maintain SOPs, work instructions, guidance documents, and quality tools
Lead quality improvement initiatives and support continuous process optimization
Foster a culture of quality, compliance, and proactive risk management throughout the organization
Prepare clear, concise reports summarizing audit outcomes, risk assessments, and quality metrics
Ensure timely and accurate documentation in the Trial Master File (TMF)
Present quality trends, risks, and recommendations to management and cross‑functional teams

Qualification

Clinical Quality Management SystemGCP compliance oversightRisk-based quality managementClinical auditsICH-GCP knowledgeRegulatory requirements knowledgeAnalytical thinkingAttention to detailProblem-solving skillsCollaboration skills

Required

Bachelor's degree in life sciences, nursing, pharmacy, or related field
5–10+ years of experience in clinical research, with a minimum of 3 years in Quality Assurance or Clinical Compliance
Deep knowledge of ICH‑GCP, FDA, EMA, and other global clinical regulatory requirements
Experience conducting clinical site, vendor, and/or system audits
Strong understanding of risk‑based monitoring and QbD principles
Excellent communication, problem‑solving, and relationship‑building skills
Analytical and strategic thinking to identify and address quality risks
Attention to detail and strong documentation habits
Diplomacy and collaboration, working effectively across functions
Proactive problem‑solving with a continuous improvement mindset
Ability to manage multiple priorities in a fast‑paced environment

Benefits

Competitive Health and Dental programs with flexible plan offerings, including FSA and HSA programs
401(k) program participation with competitive company matched contributions
Eligibility to participate in Solid’s Employee Stock Purchase Plan
Mobile phone subsidy for eligible employees
Tuition Reimbursement
Vision Coverage
Life Insurance
Voluntary Pet Insurance
Employee Discount Program on Travel, Entertainment, and Services
Daily Subsidized Lunch Delivery (onsite @ Hood Park)
Free Onsite Full-Service Gym (onsite @ Hood Park)
Employee Parking (onsite @ Hood Park)

Company

Solid Biosciences

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Solid Biosciences is a life science company that conducts research for the treatment of Duchenne muscular dystrophy.
dateFounded in 2014
location
Charlestown, Massachusetts, USA
people-size51-200 employees
web-link
http://solidbio.com/

H1B Sponsorship

Solid Biosciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (3)
2023 (2)
2022 (4)
2021 (2)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$810.3M
Key Investors
Ultragenyx PharmaceuticalPerceptive AdvisorsJP Morgan
2025-02-18Post Ipo Equity· $200M
2024-01-08Post Ipo Equity· $109M
2022-09-30Post Ipo Equity· $75M

Leadership Team

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Alexander Cumbo
CEO and President
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Kevin Tan
Chief Financial Officer
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Recent News

GlobeNewswire
Solid Biosciences Provides 2026 Outlook Underscoring Neuromuscular and Cardiac Pipeline Momentum and Expanded Access to Next-Generation Capsid AAV-SLB101
2026-01-16
Pharmaceutical Technology
JPM26: Solid Biosciences banks on its AAV capsid to catalyse gene therapy success
2026-01-16
GlobeNewswire
Solid Biosciences Receives FDA Orphan Drug Designation for SGT-212 Dual-Route Gene Therapy for the Treatment of Friedreich’s Ataxia
2026-01-13
Company data provided by crunchbase