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
