Senior Director, GCP Quality Assurance
Cambridge, MA
Development – Quality Assurance /
Full-Time /
Hybrid
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 Senior Director, GCP Quality Assurance will be relied upon as Subject Matter Expert in GCP Compliance with respect to planning, execution and close-out Clinical Studies. The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and 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 Vice President of Quality Assurance.
Reporting to the Head of Quality Assurance, the Director/Sr. Director, Clinical Quality Assurance (CQA) is responsible for the development and implementation of processes and programs that provide quality and compliance oversight utilizing proactive end to end strategies for all clinical development programs, and pharmacovigilance activities. The incumbent is also responsible for the process and program that ensures appropriate computer system validation/assurance activities are completed for applicable clinical systems. The incumbent builds collaborative, supportive relationships and serves as the single point of accountability for Quality Assurance across all clinical development programs including Clinical Operations, Pharmacovigilance, Data Management, Biometrics and other relevant stakeholders. Supports and maintains a quality-focused culture and mindset across the organization.
Position Responsibilities
- Develop collaborative partnerships with Clinical Operations, Pharmacovigilance, Data Management, Biometrics, Medical Writing and Regulatory Affairs leadership to maintain a current understanding of potential areas of quality risk exposure across all studies.
- Ensure the clinical quality assurance activities are comprehensively managed. Implements GCP QA activities that support an outcome of compliance and adherence to US and ROW relevant laws, regulations, guidance; upholds the rights and welfare of patients; is focused on data integrity and end to end quality assurance activities.
- Develop and lead program for reviews, assessments, and resolution of evolving issues, including process/program reviews to identify improved approaches that will prevent quality issue recurrence (e.g. issue escalation and management; and applicable corrective/preventative action programs, periodic internal audit/gap assessment).
- Manage Scholar Rock Clinical Investigator Site audit program ensuring robust collaboration with Clinical Operations to ensure that site audits well-planned and are conducted in accordance with Scholar Rock SOPs and Audit plans.
- Represent clinical quality expertise across the organization. Communicate changing regulatory requirements, evaluate new/updated regulations and guidance. Work cross-functionally to identify potential gaps in current process. Provide related training.
- Manage the clinical inspection 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 with 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.
- Maintain accountability for ensuring risk-based strategies are utilized when managing and mitigating quality issues and to make certain that 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 10+ years of experience in the bio-pharmaceutical R&D industry. A minimum of 8 years of current, hands-on GCP Quality Assurance experience.
- Minimum 4 years of managerial experience 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.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
