Keisha Wiggs
Knightdale,NC
Summary
In-depth Quality Assurance Specialist with success in prioritization and multitasking. Exceptional communication and organizational skills. Committed to paying impeccable attention to reviews and auditing procedures.
Overview
26
26
years of professional experience
1
1
Certification
Work History
RQA SENIOR QUALITY ASSOCIATE (contract)
SAGE THERAPEUTICS
2024.06 - Current
- Provide audit support for the clinical study audit and REMS programs
- Assist in tracking and administrative close out of clinical study oversight and document audit activities
- Plan, conduct, and report on assigned REMS audits of Specialty Pharmacies (SPs), Specialty Distributors (SDs), and Healthcare Setting (HCS) to assess compliance with REMS requirements
- Assist in oversight of REMS audits of certified Healthcare Settings (HCS) to ensure conduct in a timely manner and meet REMS requirements; escalate and evaluate compliance critical events as appropriate
- Ensure timely issuance of audit reports and audit observations, oversee the audit response process, and drive audits to closure for both clinical study and REMS audit programs
- Ensure REMS audit CAPAs, non-compliance events, program deviations, and change controls are reported accurately (Veeva) and completed in a timely manner
- Ensure REMS Specialty Pharmacies (SPs), Specialty Distributors (SDs), and third-party vendors operate in compliance with the REMS requirements
- Provide data to assess risks, generate quality metrics, and review lessons learned as requested
- Reporting of key metrics (KPIs), periodic quality reports, and audits.
- Self-motivated, with a strong sense of personal responsibility.
REMS PROGRAM LEAD
Biogen
2021.01 - 2024.06
- Engages in operational development, support, maintenance, implementation and sustainment of actions and programs that support regulatory requirements, agency inspections, and supports mock audits through inspection readiness/ready room practices
- Collaborates with Global Safety and Regulatory Sciences (GSRS) Team, Corporate Compliance, Quality Assurance Manager, and operational managers to ensure optimal readiness for regulatory agency inspections
- Ensure REMS audit CAPAs, non-compliance events, program deviations, and change controls are reported accurately (Trackwise) and completed in a timely manner
- Update CRM and other FDA-validated databases, in accordance with applicable SOPs.
- Analyzed trends and data to inform decision-making and program development.
- Researched best practices and developed strategies to improve program outcomes.
- Monitored program performance and outcomes for successful delivery of services.
- Reduced non-compliance incidents by designing and implementing an internal control framework tailored to organizational needs.
- Enhanced compliance monitoring by implementing risk-based audit plans and procedures.
REMS COMPLIANCE TEAM LEAD
BIOGEN
2010.01 - 2021.01
- Assist leadership with support and management of 10-12 REMS Compliance coordinators to lead/facilitate team meetings, 1:1 weekly meeting, coaching, WFM adherence, and scheduling
- Build rapport and developed relationships with key territory physician/hospital accounts for Southeastern US areas that prescribe or infuse Tysabri therapies for multiple sclerosis
- Investigate root cause analysis of protocol deviations to Tysabri REMS Program
- Identify areas of non-compliance and collaborate via variety of communication methods including inbound/outbound calls, faxes and emails with field-based employees and other workgroups for escalation and resolution
- Ensure REMS audit CAPAs, non-compliance events, program deviations, and change controls are reported accurately (Trackwise) and completed in timely manner
- Support REMS program documentation support via form queue maintenance, source document review, error detection and entering data into Salesforce
- Presented findings from compliance audits to senior management, recommending strategies for continuous improvement in controls and processes.
SR. CASE MANAGER - Neurology
Biogen
2006.01 - 2010.01
- Manager 4-state territory through inbound/outbound calling to build and maintain collaborative relationships with patients, health care providers, sales representatives, business service partners and infusion site health care providers
- Trained and mentored team of 25 new case managers resulting in better customer experience for patients and health care professionals
- Interface with Specialty pharmacies to pull through patient situations and escalations while partnering with appropriate field teams (FAM/RDAE/RDRM)
- Initiate first patient contact once Start Form received in order to introduce appropriate next steps and support all incoming customer calls
- Lead coordination of subsequent dosing (post 1st dose), by confirming product shipment (w/SOC and SP/SD) and monitoring existing patients through Prior Authorization approvals/denials (support FAM), to proactively alert team members of obstacles, so patients are ready and compliant for dosing appointments
- Coordinate nursing services, manage support services for patients including, but not limited to Financial Assistance enrollment, PAP and Interim dose orders, Copay attestation receipt, and entering AE reports
- Pre-Huddle Call Preparation (work w/FAM to prioritize patients, disseminate dashboard to team) so team can effectively identify and remove barriers.
HR SERVICE CENTER REPRESENTATIVE
FIRST CITIZENS BANK
2002.01 - 2005.01
- Provide telephone and email support to administer employee benefit plans, HR policies and procedures through application of Title VII, FMLA, ADA, and Worker’s Compensation
- Address US employee payroll and timekeeping inquiries
- Processed new hire, transfer, and termination paperwork and conducted exit interviews, analyze exit trending, and create reports.
- Supported new hires in adapting quickly to their roles through mentorship, guidance, and sharing of best practices.
PAYROLL AND BENEFITS CASE MANAGER
NORTEL NETWORKS
1999.01 - 2002.01
- Provided support for complex human resource issues pertaining to health welfare, 401(k) and retirement, and compensation for approximately 22,000-client base associates
- Served as primary contact to third party administrators to resolve complex client issues.
Education
MBA - HR Management -
Liberty University
Lynchburg, VA12.2012
BA Political Science and Sociology -
THE University of North Carolina – Greensboro
Greensboro, NC12.1999
Skills
- GMP Knowledge
- CAPA Management
- Quality Management Systems
- Change Control Management
- Customer Service
- Analytical Thinking
- Project Management
- Risk Management
- Usability Testing
- External Audits
- Teamwork and Collaboration
- Problem-Solving
- Documentation Review
- Quality Assurance
- HIPAA Compliance
- Prescription Coordination
- Proficiency Salesforce/Health Cloud
Accomplishments
- President's Award 2022
- Operational Excellence Award 2017
- The Partnership, Inc. NC Leadership Accelerator Alum
- Supervised team of 10-12 staff members
Certification
- Lean Six Sigma Greenbelt
- PHR Certification
- The Partnership, Inc. NC Leadership Accelerator Alum
Timeline
RQA SENIOR QUALITY ASSOCIATE (contract)
SAGE THERAPEUTICS
2024.06 - Current
REMS PROGRAM LEAD
Biogen
2021.01 - 2024.06
REMS COMPLIANCE TEAM LEAD
BIOGEN
2010.01 - 2021.01
SR. CASE MANAGER - Neurology
Biogen
2006.01 - 2010.01
HR SERVICE CENTER REPRESENTATIVE
FIRST CITIZENS BANK
2002.01 - 2005.01
PAYROLL AND BENEFITS CASE MANAGER
NORTEL NETWORKS
1999.01 - 2002.01
MBA - HR Management -
Liberty University
BA Political Science and Sociology -
THE University of North Carolina – Greensboro
- Lean Six Sigma Greenbelt
- PHR Certification
- The Partnership, Inc. NC Leadership Accelerator Alum
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