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Associate Director/Director, Clinical Quality Audit Management

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.
 
Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.

Summary of Position:

Playing a critical role within Scholar Rock, the Associate Director/Director of Clinical Quality Audit Management 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. 

Position Responsibilities:

    • 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 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).

Candidate 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.
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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Scholar Rock

Category

Management

Employment type

Full-Time

Location

Remote

Salary range

Prefer not to share

Posted

9 hours ago

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