Dianthus Therapeutics - Director, Clinical Quality Assurance

Remote - USA *2mo ago

Remote Director NA Pharmaceuticals Biotechnology CRO Clinical Director Quality Assurance GCP CRO Vendor Management Clinical Trials

Requirements

• BS or MS degree in life sciences or related field required. • 12+ years of experience in GxP with minimum of 5+ years in GCP within the biotech or pharmaceutical industry. • Deep knowledge of GCP regulations and guidance’s (e.g. ICH, FDA, EMA, MHRA, etc.) • Demonstrated experience supporting or leading submissions and regulatory inspections (e.g. BLA, PMA, BIMO). • Deep expertise of Sponsor oversight and CRO/vendor management responsibilities. • Deep expertise in data integrity principles and risk-based quality management. • Demonstrated experience in clinical audit strategies including investigator site audits, audit execution, and CAPA management. • Experience working with or managing eQMS platforms and quality processes. • Knowledge of Clinical Quality Systems. • Experience with project management processes / tools to support in meetings, assist with project planning, and facilitate completion of tasks. • Proven ability to lead strategically while remaining hands-on in a fast-paced biotech environment and risk-based thinking is critical. • Proven capability to drive alignment and influence stakeholders across global, cross-functional organizations. • Ability to translate regulatory expectations into practice, risk-based solutions. • Excellent communication skills with the ability to engage senior leadership and regulatory inspectors.

Responsibilities

• Provide proactive, risk-based quality oversight for global clinical trials across all phases (e.g. Phase I, II, and III). • Serve as the primary QA lead for clinical development programs, ensuring quality is embedded from study design through close-out. • Ensure compliance with ICH E6 (R3) GCP and applicable global regulations (e.g. FDA, EMA, MHRA, etc.) • Provide expert guidance on quality risk management, issue escalation, and mitigation strategies. • Establish and maintain robust sponsor oversight frameworks for CROs and other third-party vendors. • Ensure effective oversight of delegated activities, including monitoring, data management, and safety management. • Collaborate with the Quality Unit to assess vendor qualification, performance metrics, and compliance trends. • Lead and execute a risk-based GCP audit program, including investigator site audits, clinical vendor/CRO audits, and clinical process/system audits. • Align audit strategy with clinical milestones and BLA readiness. • Oversee audit findings, CAPAs, and effectiveness checks, ensuring timely and sustainable resolution. • Ensure data integrity principles (ALCOA++) are embedded across clinical programs. • Partner with the Director/Sr. Director of Clinical Quality Systems and the Sr. Director of Quality Systems and Compliance to support inspection readiness activities, provide audit insights and risk signals, contribute to inspection strategy and preparation. • Participate in regulatory inspections as a QA subject matter expert. • Act as a trusted advisor to Clinical Development and Operations leadership. • Drive a culture of quality, compliance, and continuous improvement. • Provide QA input and conduct QC of protocols, amendments, CSRs, and regulatory submission components. • Provide quality oversight of bioanalytical activities, including review of bioanalytical method validation documentation to ensure alignment with regulatory expectations and clinical program needs. • Lead or contribute to quality governance forums and risk review boards. • Identify and assess systemic quality risks and compliance gaps • Ensure appropriate classification and management of protocol deviations, serious breaches, and inspection findings. • Escalate critical risks to senior leadership with clear, risk-based recommendations. • Additional duties may be identified by functional management based on current project/business objectives. • Some travel (approx. 20%) is required for company meetings and support of audits or regulatory inspections (e.g. in support of Sr. Director Quality Compliance as needed).