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Margarita Vulfova

@margaritavulfova

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Experienced supplier quality specialist driving regulatory compliance and supplier performance improvements.

United States

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What I'm looking for

I seek a role leading supplier quality and regulatory compliance where I can drive audits, CAPA, process improvements, and cross-functional quality systems.

I am a results-driven Quality Assurance professional with extensive experience in supplier qualification, audits, and regulatory compliance within the pharmaceutical and medical device industries.

I have managed quality systems aligned with medical device and pharmaceutical regulations, led CAPA, change control, complaints handling, batch review and release, and risk management activities including FMEA.

My background includes performing external supplier audits, hosting customer and regulatory inspections, authoring annual product reviews, and harmonizing global quality policies to ensure consistent compliance and product quality.

I excel at cross-functional communication, root-cause analysis, continuous improvement, and implementing robust quality control systems that strengthen supplier relationships and deliver measurable quality outcomes.

Experience

Work history, roles, and key accomplishments

Current

Manager, Quality Assurance

Current

RegenLab

Jan 2025 - Present (8 months)

Manage the Quality System per medical device regulations, driving CAPA, change control, complaints, audits and risk management including FMEA and batch review to ensure compliant product release.

Quality Management Systems CAPA Change Control D P FMEA Audit Batch Regulatory Compliance Complaint Handling

Supplier Quality Specialist

Lohmann Therapy Systems LTS Corp.

Nov 2018 - Jan 2025 (6 years 2 months)

Maintained supplier qualification system, performed external supplier audits, authored annual product reviews, managed QA agreements and supported regulatory and customer audits to ensure supplier compliance.

Annual Product Review Supplier Management CAPA

Quality Assurance Specialist III

Alcami Corporation

Apr 2017 - Nov 2018 (1 year 7 months)

Reviewed and approved laboratory investigations, deviations, CAPAs, change controls and validation protocols; supported regulatory compliance and FDA inspections through audit facilitation and documentation control.

CAPA Change Control Calibration Oversight Regulatory Compliance Audit Support

Quality Assurance Associate

Epic Pharmaceuticals

Oct 2010 - Apr 2017 (6 years 6 months)

Reviewed and approved production batch records, validation batches and certificates of conformance, coordinated product release and led investigations, root cause analysis and CAPA to ensure cGMP compliance.

Batch Record Review Validation CAPA Root Cause Analysis Change Control

Quality Control Analytical Chemist

Epic Pharmaceuticals

Oct 2008 - Oct 2010 (2 years)

Performed QC testing for solid oral and topical products including stability, assay, related substances and dissolution using HPLC, UV, IR and Karl Fischer, ensuring SOP and cGMP compliance.

IR業務 Karl Fischer Stability Testing