Director, Clinical Quality Assurance
About The Position
Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich’s ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. We are advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care. Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases. We are seeking a Clinical Quality Assurance (CQA) Director who is responsible for establishing, implementing, and maintaining quality systems and risk‑management practices that ensure clinical trials are conducted in compliance with ICH‑GCP, applicable regulatory requirements, internal SOPs, and industry best practices. The individual is this role is responsible for quality management and oversight of clinical trials, clinical audit program, and risks across the clinical portfolio, in partnership with cross‑functional teams to proactively improve quality and trial execution. This role will report to the Head of Quality. The position is remote and full time. Solid’s Corporate Headquarters is located in Hood Park in Charlestown, MA and it is preferred that the individual in this role be available to come on-site periodically throughout the year.
Requirements
- 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.
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.
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)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
51-100 employees
