Director, Clinical Quality Assurance

5 days ago

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Scholar Rock

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💰 $205M Post-IPO Equity on 2022-06

Description

• Playing a critical role within Scholar Rock, the Director, Clinical Quality Assurance (CQA) will be relied upon as Subject Matter Expert in GCP Compliance with respect to planning, execution and close-out Clinical Studies. • The Director, CQA coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Drug Safety/Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies. • This is a high visibility role and will be directly involved in development and continuous improvement of GCP Quality and overall Quality Management Systems at Scholar Rock as we grow and mature organizationally. • This individual will be responsible for coordinating with key stakeholders to develop/implement processes and systems governing GCP activities and will report into the Senior Director of CQA. • The Director of CQA is responsible for the development and the development and support of processes and programs that provide quality and compliance oversight utilizing proactive end to end strategies for all clinical development programs, and drug safety/pharmacovigilance activities. • The incumbent builds collaborative, supportive relationships and serves as a primary point of accountability for Clinical Quality Assurance across all clinical development programs including Clinical Operations, drug Safety/Pharmacovigilance, Data Management, Biometrics and other relevant stakeholders. • The incumbent will help to foster, support and maintain a quality-focused culture and mindset across the organization.

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.