Susan Smyth Email & Phone Number

United States

Whippany, New Jersey, United States

• Serve as a subject matter expert in CAPA Management, working globally with GCP Audit and Inspection Management, R&D and Regulatory Quality, and Study Operations teams to establish and oversee over approximately 30 CAPAs.• Chair Clinical CAPA Committee Meetings, co-author and maintain the Clinical CAPA Committee Charter, and lead the development of processes ensuring compliance with ICH-GCP regulatory requirements.• Foster collaboration, transparency, and continuous improvement through initiative to reduce complexity and bottlenecks through status updates, metrics, analytics, and the creation of solutions for CD&O stakeholders. This process improvement provides clarity for stakeholders to conserve time and costs. • Streamline complex QSDs for Clinical Development and Operations and improve clarity of roles and descriptions. • Promote inspection readiness for Clinical Trials by performing Process Quality Control checks utilizing supportive systems such as CTMS Veeva Vault Clinical, IMPACT, and Quality Database. Analyze performance measures and propose actions for risk mitigation based on GCP audit findings and quality metrics.

Whippany, New Jersey, United States

• Facilitate Interdepartmental Communication on Quality Matters: Ensure smooth exchange of information between various functions to address quality concerns effectively.• Leadership in CAPA Oversight: Chair the Clinical CAPA Committee to identify and resolve Corrective and Preventive Actions, enhancing clinical trial quality.• Global Collaboration on CAPA Initiatives: Collaborate with RD&Q to align CAPA initiatives globally, maintaining consistent standards and practices.• Expertise in CAPA and Risk Mitigation: Provide specialized knowledge on CAPA and risk mitigation, crucial for maintaining integrity in early clinical development trials.• Capacity Building and Process Improvement: Lead proactive gap identification, root cause analysis, and mentorship to strengthen quality management practices.

Whippany, New Jersey, United States

• Achieved operational excellence by optimizing processes and implementing best practice documents in early clinical development Phase I-IIa trials, First in Man (FIM)/Healthy Volunteers, and observational studies.• Developed comprehensive training tools for Clinical Sciences for preferred external partners, enhancing their proficiency in trial protocols and reducing protocol deviations.• Collaborated closely with Process Quality Management to streamline monitoring and site oversight processes, reducing complexity and bolstering support for study teams.• Spearheaded oversight project meetings with external partners, ensuring alignment on key objectives and facilitating effective communication for timely issue resolution.• Established key performance indicator (KPI) metrics for oversight meetings with external partners, enabling clear performance evaluation and driving continuous improvement efforts.

• Spearhead cross-functional teams in crafting comprehensive study plans for Phase II-III trials, ensuring alignment with project objectives and regulatory standards.• Provide vigilant oversight throughout trial execution to ensure strict adherence to study timelines and compliance with ICH-GCP guidelines for enrollment and recruitment.• Lead the core study team in translating study concepts into robust clinical study protocols and related documentation, ensuring clarity, completeness, and regulatory compliance.• Exercise diligent financial stewardship by managing and monitoring study budgets ranging from 2 million to 5 million dollars, optimizing resource allocation and cost-effectiveness.• Take charge of preparing and meticulously reviewing all project study plans, guaranteeing accuracy, consistency, and alignment with study objectives and regulatory requirements.• Chair dynamic and productive study team meetings, fostering collaboration and communication among core and extended team members to drive progress, resolve challenges, and achieve study milestones effectively.

Bachelor Of Science - Bs- Nursing, Registered Nursing/Registered Nurse

Bachelor Of Arts - Ba-Marketing, Business Administration In Management And Marketing