Kyle Adams
King of Prussia,PA
Summary
Senior Quality Assurance professional with 9+ years of experience supporting GMP pharmaceutical manufacturing across small molecule, biologics, vaccines, injectable medical devices, and gene/cell therapy. Expertise in Quality Operations, batch record review and disposition, QMS governance, vendor and CDMO oversight, and FDA/EMA/ICH regulatory compliance. Proven contributor across Big Pharma, Biotech, and CDMO environments.
Overview
10
10
years of professional experience
Work History
Quality Compliance Manager
Glenmark Pharmaceuticals
08.2025 - Current
- Managed QMS processes including deviations, incidents, CAPAs, change controls, risk assessments, batch records, and product quality complaints.
- Led Quality Management Review meetings and trended quality KPIs for management reporting.
- Coordinated internal and external audits and ensured DSCSA compliance for Rx pharmaceutical products.
- Managed SOP lifecycle, training effectiveness, and FDA DQRS case coordination.
- Location Noted | Dates As Listed
- Tracked corrective action reports and confirmed closure of corrective action requests to demonstrate adherence to quality standards.
- Maintained quality system documentation and updated specific documents to reflect new audit or test results.
Senior Quality Vendor Manager
Vertex Pharmaceuticals
06.2023 - 06.2025
- Led Vendor Quality Management (VQM) activities supporting GMP manufacturing and external CMOs.
- Oversaw NCRs, investigations, CAPAs, deviations, change controls, and batch record review/disposition.
- Developed and maintained Quality Policies, SOPs, and vendor oversight documentation.
- Designed and maintained a Quality Dashboard tracking KPIs including audit findings, compliance rates, and CAPA effectiveness.
- Led internal, external, and vendor audits to ensure inspection readiness and continuous compliance.
Project Quality Manager
Merck Pharmaceuticals
04.2021 - 05.2022
- Defined quality requirements for CMO-submitted change controls, ensuring compliance with 21 CFR Parts 210/211, ICH, and EU GMP prior to batch release.
- Provided QA leadership for validation master plans, audits, inspections, QMS governance, customer complaints, and change management.
- Managed deviations, investigations, and CAPAs in Veeva eQMS, ensuring on-time closure and regulatory compliance.
- Led vendor and CDMO oversight for CMC projects, clinical trial material disposition, and IND/BLA submissions.
- Supported batch release/rejection, lot disposition, quality agreements, regulatory filings, and risk management using FMEA.
Quality Assurance Specialist/Manager
AstraZeneca Pharmaceuticals
03.2016 - 04.2021
- Supported GMP quality systems across manufacturing and supply operations.
- Led and supported internal, external, and regulatory audits, ensuring inspection readiness.
- Provided oversight for batch review & disposition, deviations, change controls, and investigations.
- Maintained quality system documentation and updated specific documents to reflect new audit or test results.
- Partnered cross-functionally to maintain compliance with FDA, EMA, and ICH guidelines.
Education
Bachelor of Science - Chemistry | Minor: Psychology
Villanova University – School of Liberal Arts And Sciences
Philadelphia, PAMaster of Biomedical Sciences - undefined
Thomas Jefferson University
Skills
- GMP Quality Operations & QMS Governance, Batch Record Review & Disposition, Deviations, Investigations, CAPA, Change Control
- Vendor & CDMO Oversight
- FDA, EMA, ICH, EU GMP Compliance
- 21 CFR Parts 11, 210, 211, 820
- ISO 13485, 9001, 14971
- Gene & Cell Therapy / ATMPs
- SOP Authoring & Document Control
- Quality Metrics, KPIs & Trending
- Risk Management (FMEA)
- Veeva eQMS, PharmaSuite, Microsoft Office
- PMP Six Sigma Certified Laboratory Technician CQA Certified
Timeline
Quality Compliance Manager
Glenmark Pharmaceuticals
08.2025 - Current
Senior Quality Vendor Manager
Vertex Pharmaceuticals
06.2023 - 06.2025
Project Quality Manager
Merck Pharmaceuticals
04.2021 - 05.2022
Quality Assurance Specialist/Manager
AstraZeneca Pharmaceuticals
03.2016 - 04.2021
Master of Biomedical Sciences - undefined
Thomas Jefferson University
Bachelor of Science - Chemistry | Minor: Psychology
Villanova University – School of Liberal Arts And Sciences