Associate Director, Clinical Quality Audit Manager

Summary

Join Scholar Rock as the Associate Director/Director of Clinical Quality Audit Management and lead the Clinical Quality Audit Program. This high-visibility role involves developing and improving the program, coordinating with stakeholders, and reporting to the Senior Director of CQA. You will manage a team of auditors, oversee audits, maintain documentation, and support the internal audit program. The position requires collaboration with cross-functional departments and promoting quality and risk management principles. You will contribute to clinical inspection preparation and readiness, and partner with stakeholders to develop quality metrics.

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 4 years of current, hands-on CQA experience
• Minimum of 2 years of audit management experience, 1+ years directly leading people and/or leadership experience leading teams, projects, programs or directing the allocation of resources required
• Experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs)
• Demonstrated knowledge and application of FDA regulations and ICH guidance for GCP, GVP, GLP/GCLP and CSV 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

• Lead the Clinical Quality Assurance Audit Program, reporting directly to the Senior Director Clinical Quality Assurance
• Manage a team of auditors with responsibility for audit oversight of Investigator Site audits, GCP/GVP/GLP/GCLP/CSV vendor audits
• Manage Scholar Rock Clinical Investigator Site audit program ensuring robust collaboration with Clinical Operations to ensure that site audits are well-planned conducted in accordance with Scholar Rock SOPs and Audit plans. Reviews/approves all related audit materials including audit reports and audit observation responses
• Maintain all audit documentation in eDMS
• Maintain GCP/GLP/GCLP/GVP/CSV audit schedule
• Support the internal audit program ensuring alignment with the internal policies and procedures, applicable regulations, and standards of practice
• Provide consultation on corrective and preventive actions performed as a result of observations; follows-up and provides data required to determine the timeliness and effectiveness of corrective and preventive actions performed by the operational business units
• Provide data required for key performance metrics related to GCP/GLP/GCLP/GVP/CSV audit performance, associated CAPAs for Quality Review
• Represent clinical quality expertise across the organization
• 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)