Running Assays in Lab
NC State University
Paul has worked in Quality and Compliance for 25 years in the biotech and pharmaceutical industry, specializing in cell and gene therapy, biologics and small molecule drug products. With an in-depth knowledge of global health regulations and extensive expertise on GMP, GTP and GDP audits, Paul has led over 500 audits in the Americas, Europe and Asia. Prior to becoming a consultant in 2020, Paul had been a Quality leader in a wide range of GxP audit functions working for Biogen, Takeda, Merck, Sanofi and Bluebird Bio. Paul graduated from the University of Massachusetts with a BS in Biology. Paul's diverse experience, collaborative attitude, demonstrated leadership, passion for Quality and commitment to patient safety have made him the well-respected Quality leader he is today.
During Paul's time as the Director of Quality Compliance at Bluebird Bio, he grew and evolved his team to a state of managing audits globally across GxP activities including Apheresis and Cell Collection Centers. Paul was a key contributor to scaling Bluebird Bio from a clinical stage company to a commercial ready company, while building out the global Quality Compliance team and GxP Audit Program.
Paul has vast experience leading audits including Apheresis and Cell collection Centers, Infusion Sites, Drug Product and Drug Substance CDMOs, Testing Laboratories, Raw Material Suppliers, Medical Device Manufacturers, Packaging Sites, and Warehouse/Distribution Centers. In addition to performing audits, Paul has performed FDA mock inspections to ensure companies are in a state of inspection readiness. As part of these activities, Paul has trained, mentored and coached employees in preparation for regulatory inspections. Paul has also assisted companies with the development of key Quality System programs such as Vendor Qualification and Auditor Qualification programs.
Sterile Manufacturing course at North Carolina State University.
NC State University
NC State University
NC State University
I worked with Paul in the Global GXP team at Biogen Idec, in Cambridge, MA, USA. Paul is knowledgeable in quality management and regulatory compliance, as it applies to GMP, and was building his competency in GCP. Paul is a self-starter, who is highly motivated and organized. Paul is a team player and demonstrated his leadership skills with his ability to inspire and motivate his peers. He is proactive and would often present ideas and solutions to senior management, to address challenges which faced the team. I came to appreciate Paul’s dedication, and willingness to learn and advance his skills. I am happy to recommend Paul and would work with him again.
