Rachele Abilhomme
Manchester,NH
Summary
Results-driven professional with extensive experience in quality assurance, complaint management, regulatory compliance, and operational efficiency across pharmaceutical, healthcare, and insurance industries. Skilled in leading teams, process improvement, CAPA facilitation, customer service management, and cross-functional collaboration. Adept at analyzing quality metrics, implementing training programs, and ensuring compliance with FDA, ISO, and industry regulations. Passionate about driving continuous improvement and delivering high-quality service.
Collaborative leader partners 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
22
22
years of professional experience
Work History
Quality Customer Service Manager
ByHeart Inc.
06.2024 - 11.2024
- Led a 12-person complaint handling and customer service team, streamlined workflow and complaint improve resolution times by 20%
- Facilitated investigations of customer complaints, ensuring thorough documentation and resolution
- Supported quality audits to ensure compliance with service standards and regulatory guidelines
- Analyzed call center metrics to drive performance improvements and enhance customer satisfaction
Product Complaints Manager
SpringWorks Therapeutics Inc.
01.2024 - 06.2024
- Managed complaint intake, triage, and investigations, ensuring adherence to quality and regulatory requirements
- Reviewed and monitored complaint and adverse event reports for compliance with regulatory requirements
- Ensured regulatory compliance in complaint handling and post-market surveillance in accordance with FDA and cGMP guidelines
Manager Global Quality Complaints
Apellis Pharmaceuticals Inc.
12.2020 - 08.2023
- Ensured regulatory compliance in the intake and triage of Product Quality Complaints, while authoring and maintaining relevant Standard Operating Procedures
- Coordinated investigations, deviations, and Corrective and Preventive Actions (CAPAs) in relation to product quality complaints, liaising with cross-functional teams for accurate and timely reporting
- Facilitated training sessions for staff on effective complaint handling practices
Manager Of Complaints
Sunovion Pharmaceuticals Inc.
12.2018 - 08.2020
- Led operational improvements across complaint intake and processing teams, reducing backlog by 25%
- Conducted complaint investigations and collaborated with regulatory teams to ensure accurate safety reporting
- Partnered with cross-functional teams to ensure compliance with adverse event reporting and regulatory standards
Senior Post-Market Surveillance Specialist
Teleflex Medical Center
01.2018 - 11.2018
- Conducted post-market complaint analysis to support product safety and quality improvements
- Facilitated sample procurement, return kit coordination, and trend analysis for risk mitigation
- Supported compliance with regulatory deadlines, overseeing tracking and reporting of corrective actions
Senior Post-Market Surveillance Specialist
Fresenius Medical Center
04.2015 - 09.2017
- Led global complaint handling initiatives, ensuring compliance with international regulations
- Managed global quality operations, ensuring compliance with FDA, ISO, and international regulatory standards
- Facilitated training on complaint handling and regulatory compliance, achieving 95% accuracy target in Medical Device Reporting
Quality Specialist II, Team Lead
Philips Healthcare
11.2010 - 04.2015
- Directed global recall programs and led a global business initiative to unify key market field action communication
- Reviewed Investigation or CAPA deliverables and clearance for Investigation
- Created and submitted timely MDRs to regulatory agencies, maintaining compliance with established deadlines
Clinical Data Manager Associate
Aptiv Solutions
05.2008 - 11.2010
- Managed project databases, ensuring data accuracy and compliance with organizational standards
- Conducted quality audits to verify data integrity, supporting the successful completion of Phase I/II clinical trials
- Coordinated resolution of project queries and data clarification forms, enhancing trial efficiency
Medical Information Coordinator
Sunovion Pharmaceuticals Inc.
09.2007 - 05.2008
- Managed medical information inquiries and archived completed data within patient case files
- Researched and responded to internal and external inquiries, developing standard response documents
Clinical Data Manager Associate
Liberty Mutual Insurance
04.2003 - 10.2007
- Investigated personal and commercial casualty claims, ensuring compliance with state and federal laws
- Negotiated settlements and provided policyholder guidance on claim-related matters
- Mentored junior adjusters, fostering a high performing team culture
Education
Master of Arts - Healthcare Administration
Walden University
Minneapolis, MNBachelor of Science - Business Administration
Becker College
Worcester, MASkills
- Complaint Management
- Investigations
- Quality Assurance
- Compliance
- Cross Functional Collaboration
- Customer Service
- Training
- Team Leadership
- Data Analysis
- Performance Metrics
- MS Office
- TrackWise
- SAP
- SharePoint
- Salesforce
- Veeva Vault
- Metric tracking
- Training and mentoring
- Complaint resolution
- Staffing coordination
Personal Information
Manager of Customer Support
Timeline
Quality Customer Service Manager
ByHeart Inc.
06.2024 - 11.2024
Product Complaints Manager
SpringWorks Therapeutics Inc.
01.2024 - 06.2024
Manager Global Quality Complaints
Apellis Pharmaceuticals Inc.
12.2020 - 08.2023
Manager Of Complaints
Sunovion Pharmaceuticals Inc.
12.2018 - 08.2020
Senior Post-Market Surveillance Specialist
Teleflex Medical Center
01.2018 - 11.2018
Senior Post-Market Surveillance Specialist
Fresenius Medical Center
04.2015 - 09.2017
Quality Specialist II, Team Lead
Philips Healthcare
11.2010 - 04.2015
Clinical Data Manager Associate
Aptiv Solutions
05.2008 - 11.2010
Medical Information Coordinator
Sunovion Pharmaceuticals Inc.
09.2007 - 05.2008
Clinical Data Manager Associate
Liberty Mutual Insurance
04.2003 - 10.2007
Master of Arts - Healthcare Administration
Walden University
Bachelor of Science - Business Administration
Becker College
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