Susan Smyth Email and Phone Number
I am a Six Sigma Greenbelt Certified manager with over 18 years of experience. I have a diverse background in both the pharmaceutical and clinical healthcare industry. My experience encompasses managing quality issues and potential risks within Clinical Development Operations, overseeing early Clinical Development, and being an SME for all Clinical Trial Processes with strong oversight of CAPA management activities and fostering global regulatory compliance. I foster inspection readiness of all trials to mitigate risk based on functional, regional, and country audit findings , quality metrics, and oversight activities. Additionally, I have been responsible for effectively communicating processing issues through sample analysis and spearheading strategic process improvement initiatives for quality control on SOPs and processes.Proactive manager in streamlining processes and championing continuous improvement reflects my commitment to excellence.I have received several accolades throughout my tenure at Bayer including:• Bayer HealthCare Special Recognition Reward, Delivering Results, 2009 • Bayer HealthCare Special Recognition Reward, team player, 2012 • Bayer HealthCare Top Performance Award, Outstanding contribution for CAPA Management in TSO, 2020 • Bayer Healthcare Top Performance Award, Role Model for successful integration of Process and Quality Managers from the former TSO organization into the established CO Q&C group , 2022
Regeneron
View- Website:
- regeneron.com
- Employees:
- 9030
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Sr. Global Development Quality ManagerRegeneron Aug 2024 - PresentUnited States
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Associate Director Of Quality And ComplianceBayer Jan 2021 - Aug 2024Whippany, 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. -
Sr. Process Quality ManagerBayer Oct 2017 - Jan 2021Whippany, 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.
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Associate Director Monitoring Excellence & Site OversightBayer Aug 2014 - Oct 2017Whippany, 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.
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Global Oncology Study ManagerBayer Sep 2008 - Sep 2014• 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.
Susan Smyth Education Details
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Registered Nursing/Registered Nurse -
Business Administration In Management And Marketing
Frequently Asked Questions about Susan Smyth
What company does Susan Smyth work for?
Susan Smyth works for Regeneron
What is Susan Smyth's role at the current company?
Susan Smyth's current role is Sr. Global Development Quality Manager.
What schools did Susan Smyth attend?
Susan Smyth attended William Paterson University Of New Jersey, William Paterson University Of New Jersey.
Who are Susan Smyth's colleagues?
Susan Smyth's colleagues are Traci Lehnhoff, Vanessa Cerny, Stephanie Rabern, Adam Wiessmann, Anne Mason, Evelyn Brito, Martin Asimis.
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Susan Tocher
Certified Diabetes Educator, Registered Dietitian Nutritionist, Private Practice OwnerRoswell, Ga3mindspring.com, laureatemed.com, laureatemed.com2 +140489XXXXX
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1aol.com4 +151362XXXXX
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Susan Smyth, PhD, NAE, FSME
Rochester, Mi -
4harpercollege.edu, comcast.net, uky.edu, uky.edu
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