Susan P. Smyth
Boonton,NJ
Summary
Accomplished at Bayer Healthcare Pharmaceuticals Inc., co-initiated process improvements and adherence to regulatory compliance, supported operational excellence in clinical trials. Possess strong team spirit, foster collaboration and adept to working cross functionally. Highly organized, agile handle of multiple tasks and self-motivated professional. Skilled in developing and implementing strategies to increase efficiency and performance. Passionate about driving business growth, create efficient ways of working and promote a positive work environment. Dedicated to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.
Overview
18
18
years of professional experience
1
1
Certificate
Work History
Associate Director of Quality & Compliance
Bayer Healthcare Pharmaceuticals Inc.
12.2021 - Current
- Act as a subject matter expert in CAPA Management activities cross-functionally and liaise globally across functions
- Manage the establishment and oversight of CAPAs as well as Risk & Issue management standards, procedures, effectiveness and documentation integrity
- Chair Clinical CAPA Committee Meetings
- Co-author the Clinical CAPA Committee Charter
- Foster collaboration and learning, provide transparent initiative status and metrics
- Co-create solutions for CD&O stakeholders needs as subject matter experts
- Lead the development and integration of processes into the internal framework to ensure clinical development activities can be conducted efficiently, effectively with high quality and compliance adherence to ICH-GCP regulatory requirements
- Streamline complex QSDs specific to Clinical Sciences/Translational study operations
- Develop tools that can create efficiencies for study teams and standardized templates
- Proactive analysis of internal and external performance measures globally to assess any gaps
- Promote activities to ensure inspection readiness of all clinical trials
- Propose actions for mitigation of risks based on GCP audit findings, inspections, quality metrics and oversee end-to-end solutions
- Perform Process Quality Control checks on processes, analyze any gaps and propose improvement initiatives
Sr. Process Quality Manager
Bayer Healthcare Pharmaceuticals Inc.
10.2017 - 12.2021
- Facilitated cross-functional team collaboration, ensuring seamless communication between departments regarding quality matters
- Member and Chair of the Clinical CAPA Committee
- Liaise with RD&Q to support information sharing to the Global CAPA Committee
- Act as subject matter expert on CAPA and Risk mitigation actions related to clinical trials in early clinical development Ph 1-2a trials
- Proactive identification of gaps in processes in formulating Corrective and Preventative Actions (CAPA) planning
- Led root cause analysis investigation with issue lead across functions and study teams within CD&O, determine the underlying issues and implement corrective actions
- Contribute to Audit Debrief meetings and support study teams in coordinating responses with corrective actions.
- Conduct Audit planning in collaboration with R&D Quality
- Expert and mentor to study teams on use of quality database
- Train CAPA Coordinators
Associate Director Monitoring Excellence & Site
Bayer Healthcare Pharmaceuticals Inc.
09.2014 - Current
- Achieved operational excellence by streamlining processes and implementing best practices documents in early clinical development Ph I-IIa clinical trials, First in Man(FIM)/Healthy volunteers and observational studies
- Developed tools to support training for Clinical Sciences preferred external partners
- Collaborate with Process Quality Management to ensure processes in monitoring and site oversight are streamlined with reduced complexity to support study teams
- Lead oversight project meetings with external partners
- Develop KPI metrics for oversight meetings with external partners.
Global Study Manager
Bayer Healthcare Pharmaceuticals Inc.
04.2007 - 09.2014
- Lead core and multi-functional team in development of Phase II - III Oncology trials
- Chaired internal and vendor meetings
- Streamlined communication between cross-functional teams, resulting in improved collaboration and timely completion of study milestones
- Implemented risk management strategies to proactively identify potential issues and/or risks before they became critical problems during the course of studies
- Collaborated closely with clinical operations teams and train CLMs to ensure smooth implementation of study protocols at participating sites, resulting in high levels of patient enrollment and retention
- Developed detailed study plans and timelines to ensure all project milestones were met within budget constraints
- Monitored study budgets, identifying opportunities for cost savings without compromising on the quality or integrity of research conducted.
- Collaborated with quality assurance teams to ensure all aspects of the study adhered to strict regulatory guidelines at every stage.
- Initiate RFP process with vendors and assist in negotiation of contracts
- Oversee budget of 1 - 5 million USD
Senior Clinical Research Associate
Berlex Laboratories
01.2006 - 09.2007
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Presented at Investigator Meetings
- Communicated project status to the study team
- Attend regularly scheduled study team meetings
- Proficient in the use of RAVE electronic data capturing systems to adhere with clinical research guidelines.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Oversight of assigned study sites, work with investigators to address any issues or concerns
- Act as a liaison between study sites, investigators, and the sponsor organization. They address any issues or concerns that may arise during the course of the trial, ensuring effective communication and collaboration.
Education
Bachelor of Science - Nursing
05.1994
Bachelor of Arts - Marketing And Management
05.1988
Skills
- Project Management
- Strategic leadership
- Analytical Thinking
- Coaching and Mentoring
- Team Collaboration and Leadership
- Relationship Building
- Process Improvement
- Operations Management
- Critical Thinking
- Regulatory Compliance
- Professional and Courteous
- Performance Tracking and Evaluation
Accomplishments
- Six Sigma Green Belt Certification, 2022
- 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
Affiliations
- AVOCA Quality Consortium
- Oncology Nursing Society
Certification
Six Sigma Yellow and Green Belt certifications
Registered Nurse Licensure, NY and NJ States
Timeline
Associate Director of Quality & Compliance - Bayer Healthcare Pharmaceuticals Inc.
12.2021 - Current
Sr. Process Quality Manager - Bayer Healthcare Pharmaceuticals Inc.
10.2017 - 12.2021
Associate Director Monitoring Excellence & Site - Bayer Healthcare Pharmaceuticals Inc.
09.2014 - Current
Global Study Manager - Bayer Healthcare Pharmaceuticals Inc.
04.2007 - 09.2014
Senior Clinical Research Associate - Berlex Laboratories
01.2006 - 09.2007
William Paterson University of New Jersey - Bachelor of Science, Nursing
William Paterson University - Bachelor of Arts, Marketing And Management
Volunteer for local NorthStar Pet Rescue
- Foster rescued dogs ranging from the age of a puppy to senior dog
- Train and acclimate rescued dogs to their new surroundings
- Behavioral training
ACKNOWLEDGEMENTS/AWARDS
- 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
Volunteer for local NorthStar Pet Rescue
- Foster rescued dogs ranging from the age of a puppy to senior dog
- Train and acclimate rescued dogs to their new surroundings
- Behavioral training
ACKNOWLEDGEMENTS/AWARDS
- 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
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