Associate Director - Clinical Quality Audits

5 days ago

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Scholar Rock

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Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Our most advanced investigational product candidate, apitegromab (SRK-015), a

51 - 200 employees

Founded 2016

💰 $205M Post-IPO Equity on 2022-06

📋 Description

•Scholar Rock is a biopharmaceutical company focused on life-changing therapies for serious diseases. •Lead the Clinical Quality Audit Program. •Coordinate with stakeholders to develop processes governing audit activities.

🎯 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. Experience in Post-Marketing PV auditing is a plus •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 •Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines •Excellent oral and written communication skills •Thrives in a fast-paced work environment •Strong team-player mentality