MARIA MCFADDEN
Boones Mill,VA
Summary
Quality and compliance leader supporting pharmaceutical, biopharmaceutical, medical device, and cosmetic manufacturing. Leads quality systems, investigations, supplier quality, validation, environmental monitoring, and audit readiness while maintaining GMP compliance. Brings oversight of quality teams, customer concerns, and performance reporting to support continuous improvement and regulatory readiness.
Overview
1
1
Certification
22
22
years of professional experience
Work History
Quality Lead
ProAmpac
Rocky Mount, Virginia
03.2026 - Current
- Led quality checks for flexible packaging production and converting operations.
- Reviewed nonconforming materials and directed containment actions.
- Completed product inspections using gauges, samples, and specification sheets.
QUALITY MANAGER
KIK Consumer Products
02.2025 - 11.2025
- Lead quality assurance programs and quality system compliance activities.
- Managed non-conformance investigations and implemented CAPA to ensure compliance and enhance product quality.
- Addressed customer quality concerns and oversaw corrective action plans to resolve issues and improve satisfaction.
- Develop and monitor quality performance metrics and KPI reporting.
- Drove continuous improvement initiatives to enhance product quality and operational effectiveness, fostering a culture of quality.
SENIOR QUALITY COMPLIANCE MANAGER
Voyant Beauty
02.2018 - 11.2024
- Directed quality department operations, ensuring compliance with the company-wide quality system.
- Led initiatives that strengthened regulatory compliance and operational efficiency.
- Reviewed and approved quality records, investigations, deviations, and compliance documentation.
- Liaised between customer quality organizations and manufacturing operations to resolve quality issues.
- Managed supplier quality programs and oversaw vendor performance to enhance product quality.
- Supported cleaning validation and process validation activities.
- Presented quality performance metrics and compliance updates to executive leadership.
QUALITY & VALIDATION CONSULTANT
ALKU, Validant, Oxford, and Microworks
Multiple, Multiple
10.2004 - 01.2018
- Executed validation projects for equipment, laboratory, and computerized systems to enhance operational integrity.
- Led cleaning validation development and execution activities.
- Conducted environmental monitoring investigations and remediated excursions to ensure compliance with regulatory standards.
- Performed root cause investigations and implemented corrective actions to resolve compliance issues and prevent future occurrences.
- Provided quality, compliance, validation, and remediation support for major pharmaceutical and biotechnology clients.
- Supported regulatory remediation and compliance improvement programs.
- Authored validation protocols, risk assessments, technical reports, and SOPs.
- Developed and delivered operator training programs.
Education
Bachelor of Science - Information Technology
Kaplan University
Davenport, IAAssociate of Applied Science - Medical Laboratory Technology
Lakeland Community College
Willoughby, OHSkills
- Quality management
- Root cause analysis and investigations
- Supplier quality management
- Quality control testing
- Manufacturing process validation
- Risk assessments
- Quality metrics and KPI reporting
- Audit readiness
- SOP development
- Laboratory operations management
- Team leadership and training
- Compliance documentation management
- KPI reporting
- Team Leadership & Training
- Quality management software
Personal Information
Title: SENIOR QUALITY & COMPLIANCE LEADER
Certification
Certified Train-the-Trainer Johnson & Johnson, Certified Clinical Research Associate Kriger International
Custom
TIP: For the strongest impact, center your name at the top in 18-20 pt bold font, use bold section headers with a horizontal line beneath each section, and keep the final document to two pages. This format is appropriate for Senior Quality Manager, Quality Director, Compliance Manager, Validation Manager, and Supplier Quality leadership roles.
Timeline
Quality Lead
ProAmpac
03.2026 - Current
QUALITY MANAGER
KIK Consumer Products
02.2025 - 11.2025
SENIOR QUALITY COMPLIANCE MANAGER
Voyant Beauty
02.2018 - 11.2024
QUALITY & VALIDATION CONSULTANT
ALKU, Validant, Oxford, and Microworks
10.2004 - 01.2018
Bachelor of Science - Information Technology
Kaplan University
Associate of Applied Science - Medical Laboratory Technology
Lakeland Community College