Daniel Bolle

About Daniel Bolle

Adept quality management professional with diverse experience in GxP quality management, supplier oversight, and compliance auditing. Furthered supplier quality management programs at 5 companies. Recognized for technical writing, cross-functional collaboration, and relationship building capabilities. Certified Quality Auditor (CQA) and Certified Manager of Quality / Organizational Excellence (CMQ/OE)Specialties: Quality system management, global regulatory standards, FDA, EMA, MHRA, Health Canada, ICH, ISO, PIC/S, sterile, biologic and ATMP (cell & gene therapy), oral solid, liquid, medical device, Good Manufacturing Practice, GMP, Good Laboratory Practice, GLP, GxP, deviation, root cause analysis, RCA, corrective and preventive action, CAPA, compliance auditing, supplier management, contract manufacturing organization, CMO, external manufacturing, supplier lifecycle, training, mentoring, TrackWise, Microsoft Office, JD Edwards, Microsoft Teams, ComplianceWire, document management, data integrity, leadership, critical thinking, decision-making

Experience

1. Gxp Auditor

   Qualifyze

   May 2024 — Present · Frankfurt am Main, DE

   Conduct contract freelance audits to GxP, ISO, or ICH guidelines focusing on pharmaceutical and medical device manufacturing clients

Education

• University of Wisconsin-Madison

  BS, Chemistry, History

Skills

• Supplier Quality
• Good Laboratory Practice (Glp)
• Quality System
• Quality Assurance
• Computer System Validation
• Capa
• Pharmaceutical Industry
• Sop
• Fda
• Regulatory Affairs
• Glp
• U.s. Title 21 Cfr Part 11 Regulation
• Change Control
• Cleaning Validation
• Validation
• Gxp
• Quality Auditing
• Aseptic Processing
• Gmp
• Iso 13485
• 21 Cfr Part 11
• Corrective and Preventive Action (Capa)