Cmq/Oe Daniel Bolle Cqa

Daniel Bolle is a highly experienced quality professional, specializing in supplier quality and compliance. Daniel has worked in various roles, demonstrating their expertise in overseeing supplier quality lifecycle, GxP audit program management, and compliance with regulatory standards.

Currently, Daniel is working at Allogene Therapeutics as an Associate Director, responsible for managing the supplier quality and compliance for the firm's cell and gene therapy-related GxP supplier network.

Before that, they worked at Akorn, Inc as the Associate Director of Global Supplier Quality, where they headed the global supplier quality program covering 1,200 GxP sources. Daniel also supervised a global team of four.

Prior to that, Daniel held the position of Senior Manager - Contract Manufacturing & Supplier Quality at Akorn, Inc. In this role, they were responsible for supplier quality management and facilitated the evaluation and onboarding of new suppliers.

Earlier in their career, Daniel worked at Baxter Healthcare as the Manager of Supplier Quality, overseeing the global quality oversight of drug, biologics, and medical device supplier network in the BioScience division.

Additionally, they gained valuable experience at American Regent, Inc. (formerly Luitpold Pharmaceuticals), where they served as Senior Specialist, overseeing supplier quality management activities. Daniel also held the position of Head of Quality Compliance, acting as a GMP quality compliance officer.

Daniel began their career at Wockhardt USA, holding roles as Supervisor of Production Quality Assurance and Supervisor of Incoming Inspection Quality Assurance.

Daniel also worked briefly as a Consultant/GLP Auditor at Advanced Earth Technologies and as a Quality Assurance Auditor and Group Leader at Safety-Kleen, where they performed internal audits and assessed compliance to GLP and ISO standards.

Throughout their career, Daniel has consistently demonstrated their ability to improve product quality and regulatory compliance through the implementation of supplier quality programs and the execution of audit processes.

Daniel Bolle, CMQ/OE, CQA, holds a Bachelor of Science degree in Chemistry and History from the University of Wisconsin-Madison. In 2005, they obtained the Certified Quality Auditor (CQA) certification from ASQ - World Headquarters. Additionally, in 2017, they obtained the Certified Manager of Quality/Organizational Excellence (CMQ/OE) certification, also from ASQ - World Headquarters.