Keisha Wiggs
KNIGHTDALE
Summary
Experienced professional specializing in case management, compliance, and quality assurance. Demonstrated success in improving organizational processes and ensuring adherence to regulatory standards. Proficient in data analysis and strategic planning, with a track record of fostering teamwork to achieve goals. Quality Manager recognized for driving productivity and efficiency while maintaining compliance and safety standards.
Overview
31
31
years of professional experience
2
2
Certifications
Work History
QUALITY MANAGER
Shepherd Safety Services at Envision Pharma
Raleigh
12.2024 - Current
- Spearheaded strategic development and tactical implementation of a comprehensive Quality Management System (QMS), encompassing REMS administration, training, regulatory compliance, pharmacovigilance, vendor management, and quality assurance.
- Acted as primary Quality Partner for REMS project teams, enhancing quality program capabilities and continuous improvement initiatives.
- Monitored quality management functions to ensure compliance with 21 CFR Part 11, ISO 9001, and GxP standards by establishing robust processes for electronic records and signatures.
- Conducted internal and vendor audits to identify nonconformities and implemented process improvements to enhance operational efficiency.
- Facilitated regulatory training sessions, increasing quality awareness within cross-functional teams.
- Directed nonconformance investigations and CAPA processes, ensuring timely reviews and closures for internal and external quality events.
- Collaborated with cross-functional teams to align vendor practices with organizational objectives while monitoring vendor performance against contractual obligations.
- Maintained comprehensive documentation of vendor evaluations, audits, and corrective actions in compliance with internal quality standards.
SR. QUALITY ASSOCIATE, RESEARCH CLINICAL AUDITOR
SAGE THERAPEUTICS
Boston
02.2023 - 11.2024
- Provided comprehensive support for clinical study audits and REMS programs to ensure compliance with regulations and organizational standards.
- Tracked and administratively closed out clinical study oversight and document audit activities in a timely manner.
- Planned, conducted, and reported on REMS audits of Specialty Pharmacies, Specialty Distributors, and Healthcare Settings.
- Ensured prompt issuance of audit reports and observations, driving audits to closure for clinical studies and REMS programs.
- Monitored and accurately reported CAPAs, non-compliance events, program deviations, and change controls using TrackWise and Veeva.
- Generated data to assess risks and create key quality metrics for informed decision-making.
- Prepared and presented periodic quality reports, KPIs, and audit outcomes to stakeholders effectively.
- Collaborated with cross-functional teams to ensure compliance with REMS requirements across various vendors.
TEAM LEADER, REMS COMPLIANCE
BIOGEN
Research Triangle Park
01.2021 - 02.2023
- Led compliance coordinators to ensure adherence to REMS requirements in patient support programs.
- Oversaw regulatory compliance, including REMS protocols and documentation accuracy.
- Facilitated communication between specialty pharmacies, healthcare providers, and compliance teams for REMS issues.
- Managed case processes to guarantee timely delivery of prescribed therapies to patients.
- Served as escalation point for complex patient scenarios, collaborating with various stakeholders.
- Monitored treatment adherence, identifying barriers to optimize patient outcomes.
- Cultivated productive relationships with patients, healthcare providers, and business partners.
- Coordinated with specialty pharmacies and vendors to resolve escalations and ensure service delivery.
SR. REMS COMPLIANCE COORDINATOR
BIOGEN
Research Triangle Park
11.2017 - 12.2020
- Managed REMS program to ensure compliance with FDA regulations and mitigate risks.
- Monitored neurology infusion patients in REMS, ensuring adherence to treatment protocols.
- Maintained comprehensive documentation for REMS, including patient logs and training materials.
- Executed risk management plans aligned with regulations, incorporating safety measures for infusions.
- Delivered training on REMS requirements and infusion monitoring to internal teams.
- Educated healthcare providers on REMS components and compliance reporting strategies.
- Collaborated with clinical teams to oversee infusion scheduling and verify patient eligibility.
- Facilitated communication between providers and REMS coordinators to improve patient care.
SR. CASE MANAGER/PATIENT NAVIGATOR
BIOGEN
02.2010 - 10.2017
- Ensured REMS compliance in patient access programs, including documentation and adherence monitoring.
- Educated patients and healthcare providers on REMS requirements and safe medication use.
- Assist patients in navigating insurance approvals, prior authorizations, and reauthorizations to ensure uninterrupted access to prescribed medications.
- Coordinate with specialty pharmacies and healthcare providers to schedule and facilitate treatment logistics, including product delivery and infusion appointments.
- Assist patients in identifying and enrolling in financial assistance programs, including copay assistance, patient assistance programs (PAP), and other resources.
- Build and maintain strong relationships with healthcare providers, sales teams, FRMs, specialty pharmacies, and other stakeholders to ensure a coordinated approach to patient care.
- Maintain accurate and up-to-date patient records in compliance with organizational policies and regulatory requirements using Salesforce.
- Report adverse events and follow-up actions promptly and appropriately.
- Monitor and analyze case data (Tableau) to identify trends, improve workflows, and enhance the overall patient experience.
NEUROLOGY CASE MANAGER
BIOGEN
02.2006 - 02.2010
- Educated patients and healthcare providers about Biogen products and services.
- Fielded/coordinated services associated with incoming calls to enable physicians and patients to start therapy including prior authorization (PA) coordination, Financial Assistance review, and Infusion site coordination.
Mental Health Technician (QP)
WAKE COUNTY GOVERNMENT, CHILD AND FAMILY CRISIS SERVICES
Raleigh
01.1995 - 04.2008
- Registered patients at 24-hour crisis center, ensuring accurate intake documentation and confidentiality compliance.
- Monitored patient safety during crisis stabilization, conducting regular checks and reporting concerns to clinical staff.
- Assisted qualified professionals in coordinating crisis assessments, treatment planning, and referrals to mental health services.
- Prepared patient charts and maintained medical records while updating electronic health systems in real time.
- Facilitated communication among patients, families, and multidisciplinary teams to ensure timely care.
- Managed scheduling, data entry, and documentation of patient encounters efficiently.
- Provided guidance on center policies and available resources to patients and families.
- Escalated urgent safety concerns to licensed clinicians for immediate intervention.
HR SHARED SERVICES SPECIALIST
FIRST CITIZENS BANK
Raleigh
01.2002 - 12.2005
- Administered HR service center operations, focusing on leave of absence management and payroll support.
- Served as primary contact for employees, providing timely responses to inquiries about HR policies.
- Processed employee data changes in HRIS, ensuring accuracy during new hires and terminations.
- Oversaw onboarding and offboarding processes, coordinating document collection and conducting exit interviews.
- Maintained accurate employee records in HRIS, supporting audits and compliance reporting.
- Provided guidance on company policies and employment laws to reinforce organizational consistency.
- Assisted with benefits enrollment, ensuring clarity regarding health insurance and retirement plans.
- Investigated common HR issues, resolving discrepancies in paychecks and benefits enrollment.
PAYROLL/BENEFITS CASE MANAGER
PricewaterhouseCoopers
RTP
01.1999 - 12.2002
- Delivered comprehensive HR support for 22,000 associates in health, welfare, and retirement programs.
- Acted as primary liaison with third-party administrators to resolve complex employee issues.
- Ensured accuracy and compliance in payroll and benefits matters for timely resolutions.
Education
MBA - Business Administration And Management
Liberty University
Lynchburg, VA05-2012
Bachelor of Science - Political Science & Sociology
University of North Carolina At Greensboro
Greensboro, NC07-1999
Skills
- Quality management
- Regulatory compliance
- CAPA processes
- Vendor management
- Audit facilitation
- Risk assessment
Certification
- Lean Six Sigma Yellow belt
- PHR Certification
- The Partnership, Inc. NC Leadership Accelerator Alum
Accomplishments
Presidents Award Biogen 2017 & 2020
Affiliations
SE Raleigh Volunteer - Food Distribution (2019-Present)
Timeline
QUALITY MANAGER
Shepherd Safety Services at Envision Pharma
12.2024 - Current
SR. QUALITY ASSOCIATE, RESEARCH CLINICAL AUDITOR
SAGE THERAPEUTICS
02.2023 - 11.2024
TEAM LEADER, REMS COMPLIANCE
BIOGEN
01.2021 - 02.2023
SR. REMS COMPLIANCE COORDINATOR
BIOGEN
11.2017 - 12.2020
SR. CASE MANAGER/PATIENT NAVIGATOR
BIOGEN
02.2010 - 10.2017
NEUROLOGY CASE MANAGER
BIOGEN
02.2006 - 02.2010
HR SHARED SERVICES SPECIALIST
FIRST CITIZENS BANK
01.2002 - 12.2005
PAYROLL/BENEFITS CASE MANAGER
PricewaterhouseCoopers
01.1999 - 12.2002
Mental Health Technician (QP)
WAKE COUNTY GOVERNMENT, CHILD AND FAMILY CRISIS SERVICES
01.1995 - 04.2008
MBA - Business Administration And Management
Liberty University
Bachelor of Science - Political Science & Sociology
University of North Carolina At Greensboro