Remote Director, Clinical Quality Assurance

Summary

Join Scholar Rock as the Director, Clinical Quality Assurance (CQA) to play a critical role in ensuring compliance with GCP regulations and developing quality management systems. This high-visibility position will coordinate with key stakeholders to develop processes and systems governing GCP activities and report into the Senior Director of CQA.

Requirements

• BA/BS degree required, advanced degree a plus
• Minimum of 8+ years of experience in the bio-pharmaceutical R&D industry. A minimum of 6 years of current, hands-on CQA experience
• Minimum of 4 years of managerial experience, 2+ years directly leading people and/or leadership experience leading teams, projects, programs or directing the allocation of resources required
• Substantial experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs)
• Demonstrated knowledge and application of ICH regulations and guidance for GCP, GVP, and GCLP activities
• Direct experience in the conduct and reporting of internal and external audits, root cause analysis and the translation of findings into corrective actions plans that mitigate risks to study subjects, data integrity and clinical programs
• Experience preparing for, participating in, and subsequent response to health authority GCP/GVP inspections/partner audits
• Ability to write clear quality position statements, risk-based audit reports, and procedures
• Ability to maintain robust collaboration with Functional Area Stakeholders while maintaining High Quality Standards
• Excellent oral and written communication skills
• Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines

Responsibilities

• Develop collaborative partnerships with Clinical Operations, Drug Safety/Pharmacovigilance, Data Management, Biometrics, Medical Writing and Regulatory Affairs leadership to maintain a current understanding of potential areas of quality risk exposure across all studies
• Ensure CQA activities are comprehensively managed. Implements CQA activities that support an outcome of compliance and adherence to US and ROW relevant laws, regulations, guidance; upholds the rights and welfare of patients; is focused on data integrity and end to end quality assurance activities
• Support the development of program(s) for reviews, assessments, and resolution of evolving issues, including process/program reviews to identify improved approaches that will prevent quality issue recurrence (e.g. issue escalation and management; and applicable corrective/preventative action programs, periodic internal audit/gap assessment)
• Support Scholar Rock Clinical Investigator Site audit program ensuring robust collaboration with Clinical Operations to ensure that site audits well-planned and are conducted in accordance with Scholar Rock SOPs and Audit plans
• Represent clinical quality expertise across the organization. Communicate changing regulatory requirements, evaluate new/updated regulations and guidance. Work cross-functionally to identify potential gaps in current process. Help to provide related training as needed
• Support the clinical inspection preparation and readiness program, and the overall clinical quality assurance strategy internally at Scholar Rock as well as at our vendors and Clinical Investigator sites
• Collaborate with multiple cross-functional departments in supporting Vendor Management to ensure clinical vendors have appropriate quality-related selection, approval, agreements, and on-going oversight through vendor audits
• Promote quality and risk management principles (e.g., quality by design, critical to quality focuses, risk assessment and risk ranking, establishment of risk thresholds and tolerance limits) when supporting innovative programs and advancing ongoing clinical programs
• Help to ensure risk-based strategies are utilized when managing and mitigating quality issues and to help to ensure that these strategies are utilized consistently across programs
• Partner with the key stakeholders (e.g., clinical, clinical operations, pharmacovigilance, and other relevant stakeholders) to develop quality metrics (e.g. KQI, KPI leading and lagging)