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Associate Director/Director, Clinical Quality Audits @Scholarrock

[Hiring] Associate Director/Director, Clinical Quality Audits @Scholarrock

Mar 25, 2025 - Scholarrock is hiring a remote Associate Director/Director, Clinical Quality Audits. 💸 Salary: unspecified. 📍Location: USA.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

Playing a critical role within Scholar Rock, the Associate Director/Director of Clinical Quality Audits will be relied upon to lead the Clinical Quality Audit Program. This is a high visibility role and will be directly involved in development and continuous improvement of the Clinical Quality Audit Program 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 the Clinical Quality Audit Program activities and will report into the Senior Director of CQA.

  • Leads the Clinical Quality Assurance Audit Program, reporting directly to the Senior Director Clinical Quality Assurance
  • Manages a team of auditors with responsibility for audit oversight of Investigator Site audits, GCP/GVP/GLP/GCLP/CSV vendor audits
  • Manages Scholar Rock Clinical Investigator Site audit program ensuring robust collaboration with Clinical Operations to ensure that site audits are well-planned and conducted in accordance with Scholar Rock SOPs and Audit plans
  • Reviews/approves all related audit materials including audit reports and audit observation responses
  • Maintains all audit documentation in eDMS
  • Maintains GCP/GLP/GCLP/GVP/CSV audit schedule
  • Supports the internal audit program ensuring alignment with the internal policies and procedures, applicable regulations, and standards of practice
  • Provides 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
  • Provides data required for key performance metrics related to GCP/GLP/GCLP/GVP/CSV audit performance, associated CAPAs for Quality Review
  • Represents 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)

Qualifications

  • 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

Benefits

  • Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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📍 Be aware of the location restriction for this remote position: USA
‼ Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
Back to Remote jobs  >   All others
Associate Director/Director, Clinical Quality Audits @Scholarrock
All others
Salary 💸 unspecified
Remote Location
USA
Job Type full-time
Posted Mar 25, 2025
Apply for this position Unlock 53,522 Remote Jobs
️
📍 Be aware of the location restriction for this remote position: USA
‼ Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
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