Associate Director - Clinical Quality Audit Management

2 days ago

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Scholar Rock

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2016

💰 $205M Post-IPO Equity on 2022-06

Description

• Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. • The Associate Director/Director of Clinical Quality Audit Management will lead the Clinical Quality Audit Program, ensuring continuous improvement and effective stakeholder collaboration.

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.