Mujde Tulin Evizi
San Diego,CA
Summary
Quality Assurance and Document Control Specialist with over eight years of experience in FDA-regulated pharmaceutical and biomedical sectors; proficient in GxP compliance and document management systems like Veeva Vault and ComplianceWire. Spearheaded a project that improved document review timelines by 35% at Bristol Myers Squibb while ensuring zero major findings during regulatory inspections. Recognized several certifications including QA & Regulatory Affairs Certification from UCSD, demonstrating commitment to industry standards and continuous improvement.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Sr. Quality Systems & Training Specialist
Creo Consulting / Dyne Therapeutics
09.2024 - 01.2025
- Administered Veeva Vault EDMS and Compliance Wire LMS ensuring compliance with 21 CFR Part 11 and company SOPs
- Orchestrated the lifecycle of 500+ GxP document review and approval workflow within Veeva Vault EDMS including drafting, formatting, ensuring timely completion, compliance, and proper reviewer/approver assignments
- Delivered GxP training on Veeva Suites and ComplianceWire to 30+ new hires monthly, enabling efficient onboarding, role-based training assignments
- Spearheaded the execution of periodic reviews for GxP documents within Veeva EDMS while monitoring implementation progress to ensure compliance and timely execution within Veeva EDMS
- Mapped non-compliance risks using gap analysis across 50+ SOPs, CVs, and job descriptions, and vendor audit files, enabling a successful FDA audit with zero critical observations and optimized workflows
- Fortified regulatory inspection preparedness by developing comprehensive training compliance trackers and audit-ready documentation, resulting in zero major FDA 483 observations during the FDA inspections
Sr. Quality Assurance Specialist
Turning Point Therapeutics (Bristol Myers Squibb)
08.2022 - 06.2023
- Facilitated the Change Control Review Board across departments from project start to finish, guaranteeing GxP vendor documentation and readiness for inspections, and maintained adherence to industry practices
- Orchestrated the review of over 2,500 QA documents and finalized more than 7,000 GxP documents within GMP, GCP, and GLP environments, while coordinating a gap analysis that contributed to PAI readiness
- Examined deviation reports, CAPAs, and non-compliance documents, ensuring adherence to GxP regulations and minimizing potential audit findings that resulted in zero critical observations during FDA inspections
- Formulated quality metrics and presented key performance indicators at monthly quality meetings, resulting in a 35% improvement in document review and closure timelines
- Developed an efficient document review process, resulting in a 25% reduction in turnaround time for critical documentation and enhanced cross-functional collaboration with CMOs and CROs
Quality Systems / Document Control & Training Specialist-Veeva Implementation
Celgene Corporation (Bristol Myers Squibb)
01.2017 - 05.2019
- Led the document mapping, implementation, and verification of a migration project from Documentum to VeevaVault, achieving 99% data integrity and enhancing compliance during system transitions
- Coordinated SOPs, policies, and WIs development for approval in Veeva, ensuring compliance with training requirements
- Created GxP training programs in Compliance Wire LMS, set up user accounts, assigned training roles for new hires, and trained employees for Veeva Docs
- Analyzed, and uploaded 1300 Vendor documents into Veeva Docs
- Directed stability projects for APIs and Drug Products for completeness and bulk migration
- Championed Change Control processes for controlled documents, maintaining current versions within Veeva eDMS, which lowered document errors by approximately 15% and improved audit readiness
Clinical QA Specialist, Document Control (Contract)
Intercept Pharmaceuticals
06.2016 - 09.2016
- Inspected 50+ batch records, documenting discrepancies, and expedited resolution by liaising between Quality Control and Manufacturing teams, ensured complete Batch Record history file is maintained in the Veeva EDMS
- Administered the vendor quality document lifecycle for 25+ external suppliers, collaborating with cross-functional teams to ensure compliance with cGMP standards and adherence to document control procedures
Quality Specialist- Data Integrity
Vital Therapies
01.2015 - 09.2015
- Company Overview: Medical Device- Biologics- Cell Therapy
- Created a batch records database by coordinating GMP manufacturing batches and QC test records with cross-functional team members and completed data integrity for continuous improvement
- Forged robust data verification processes supporting FDA BLA submission involving three clinical trials, consulting with Regulatory CMC, Quality Assurance, and R&D leadership, and reduced data errors by 15%
- Audited 110 Biological Batch Records and clinical documents, from historical to current, for regulatory submissions
- Medical Device- Biologics- Cell Therapy
Quality Control Manager
Bastas Barite Industry
01.2013 - 01.2015
- Managed quality control operations, reducing defects and improving overall product consistency and profitability by $500K
Education
Bachelor of Science - Chemistry
Ankara University
Master of Education -
Ankara University
Skills
- GxP (GCP, GLP, GMP)
- QMS
- Change Control
- CAPA
- Deviation
- Audit Readiness
- Data Integrity
- 21 CFR Part 11
- GDocP
- ICH Q7,ICH Q10
- Veeva Vault EDMS
- Document Lifecycle Management
- Documentum
- SharePoint, Box
- ZenQMS
- ComplianceWire LMS
- Training delivery
- Veeva Training
- FDA Regulations
- PAI Readiness
- Internal Audits
- Vendor Audits
- ISO 13485
- ShareFile, Smartsheet
- Project Management
- Team leadership
- MS Project
- Adobe Acrobat
- Project Planning
- Timeline Management
- Resource Allocation
- Gap Analysis
- Root Cause Analysis
- KPI Reporting
- English, Spanish, Turkish
Languages
Certification
- Regulatory Affairs Certification, Quality Assurance & Control Certification Drug Manufacturing, UCSD
- Pharmaceutical Laboratory and Sciences Certification, Southwestern College
- Advanced Project Management Certification, San Diego Continuing Education
- Regulatory Affairs Certification, Medical Devices, US-FDA, EU-EMA, CA, SDRAN
Timeline
Sr. Quality Systems & Training Specialist
Creo Consulting / Dyne Therapeutics
09.2024 - 01.2025
Sr. Quality Assurance Specialist
Turning Point Therapeutics (Bristol Myers Squibb)
08.2022 - 06.2023
Quality Systems / Document Control & Training Specialist-Veeva Implementation
Celgene Corporation (Bristol Myers Squibb)
01.2017 - 05.2019
Clinical QA Specialist, Document Control (Contract)
Intercept Pharmaceuticals
06.2016 - 09.2016
Quality Specialist- Data Integrity
Vital Therapies
01.2015 - 09.2015
Quality Control Manager
Bastas Barite Industry
01.2013 - 01.2015
Master of Education -
Ankara University
Bachelor of Science - Chemistry
Ankara University
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