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Sheung Yi Terkiewicz

@sheungyiterkiewicz

Quality compliance leader at Amicus Therapeutics who deployed TrackWise dashboards and cut overdue audit records from 48% to 3%.

United Kingdom

Message

At Amicus Therapeutics, I led audit and inspection management and quality compliance work, including deploying a VQR tracking system in TrackWise and managing an Approved Vendor List of over 200 active vendors.

I directed oversight of internal and external audit programmes, helping reduce overdue audit records from 48% to 3% within five months. I also developed KPI dashboards for audits and VQRs to improve visibility of Quality Management System performance.

As Manager, Quality Management Systems at Amicus Therapeutics, I led CAPA Review Boards and improved on-time CAPA closure from 64% to 88%. I also provided executive KPI reporting and served as the primary SME for the TrackWise CAPA module.

At Otsuka Pharmaceutical Europe, I oversaw QMS activities and led Kaizen Blitz governance sessions that reduced overdue Change Controls from 124 to zero. I also designed monthly quality dashboards and supported TrackWise Digital implementation.

Experience

Work history, roles, and key accomplishments

Senior Manager, Quality Compliance

Amicus Therapeutics

Nov 2025 - Aug 2026 (9 months)

Led cross-functional vendor qualification and audit management, reducing overdue audit records from 48% to 3% within five months. Directed audit programmes and provided TrackWise SME support.

Trackwise Supplier Qualification Audit Management KPI Dashboards Regulatory Inspections Cross functional Leadership

Senior Manager, Audit and Inspection Management

Amicus Therapeutics

Jun 2025 - Nov 2025 (5 months)

Managed audit and inspection programmes, facilitating over 100 audits annually and improving audit record timeliness. Provided TrackWise Audit and SQM expertise and supported regulatory inspections.

Trackwise Audit Management Inspection Readiness Supplier Qualification KPI Reporting Regulatory Compliance

Manager, Quality Management Systems

Amicus Therapeutics

Jun 2023 - Jun 2025 (2 years)

Led CAPA Review Boards and improved on-time CAPA closure from 64% to 88%. Delivered executive KPI reporting and served as TrackWise CAPA module SME.

CAPA Management Trackwise KPI Reporting Quality Governance Cross functional Leadership Training

QA Specialist

Otsuka Pharmaceutical Europe

Aug 2019 - Jun 2023 (3 years 10 months)

Oversaw QMS activities including Change Controls, Deviations, and CAPAs, achieving a 100% reduction in overdue Change Controls. Designed quality performance dashboards and supported regulatory inspections.

QMS Trackwise Change Control CAPA Deviation Management GMP GDP Dashboarding Vendor Management Stability Studies

QA Officer

Dextra Laboratories

Dec 2017 - Aug 2019 (1 year 8 months)

Managed QMS processes and ensured timely closure of quality records. Provided QA oversight for GMP manufacturing and supported ISO 9001:2015 accreditation.

QMS Change Control Deviations OOS CAPA GMP ISO 9001 Batch Record Review

Senior QA Specialist

Kosei Pharma

Oct 2016 - Dec 2017 (1 year 2 months)

Conducted primary review of Batch Approval Records and led incident investigations and CAPA management. Performed QMS trend analysis and statistical sampling.

Batch Record Review CAPA Root Cause Analysis QMS Trend Analysis GMP GDP

QA Specialist

Kosei Pharma

Feb 2016 - Oct 2016 (8 months)

Oversaw QMS activities including Change Controls, Deviations, Recalls, Complaints, and Returns. Conducted supplier and customer due diligence and maintained quality documentation.

QMS Change Control Deviations Recall Complaints GMP GDP Supplier Qualification