James Colanero

FAQ About James Colanero

• What is James Colanero's address?

  James Colanero is located at
  Boston, Massachusetts, United States

• What is James Colanero's job title?

  James Colanero is a
  o Leader in biotech / biopharma: Quality Assurance / Systems, Product Quality and Cross-Functional Teams; 20+ years total experience including: o 10+ years in Quality Assurance and leading people / organizations o 4 years at small/midsize companies, building QA org. + QA systems for vaccine/CGT commercial readiness o 6 years in global product quality leader roles covering new product CMC development up to launch o 14 years in site-based Technical + Operations leadership roles for both commercial, clinical products o 15+ years supporting vaccines, biologics, sterile products, and cell/gene therapies o Extensive experience also in: regulatory inspections/communications, supplier QA mgmt./collaboration, risk mgmt., eQMS (Veeva/MasterControl/Trackwise), root cause analyses, CAPAs, sterile DP, GCP/GLP regs, device regs o Driver of change and transformations for organizations, processes, and mindsets/culture o Graduate of four leadership programs across three companies; Lean Six Sigma Black Belt; nearly fluent in French o Continuously learning and being my authentic self are my most strongly held core values Biomarin Pharmaceutical

• What industry does James Colanero currently work in?

  James Colanero currently works in the
  Biomarin Pharmaceutical

• What is James Colanero's area of expertise?

  James Colanero specializes in
  o Leader in biotech / biopharma: Quality Assurance / Systems, Product Quality and Cross-Functional Teams; 20+ years total experience including: o 10+ years in Quality Assurance and leading people / organizations o 4 years at small/midsize companies, building QA org. + QA systems for vaccine/CGT commercial readiness o 6 years in global product quality leader roles covering new product CMC development up to launch o 14 years in site-based Technical + Operations leadership roles for both commercial, clinical products o 15+ years supporting vaccines, biologics, sterile products, and cell/gene therapies o Extensive experience also in: regulatory inspections/communications, supplier QA mgmt./collaboration, risk mgmt., eQMS (Veeva/MasterControl/Trackwise), root cause analyses, CAPAs, sterile DP, GCP/GLP regs, device regs o Driver of change and transformations for organizations, processes, and mindsets/culture o Graduate of four leadership programs across three companies; Lean Six Sigma Black Belt; nearly fluent in French o Continuously learning and being my authentic self are my most strongly held core values

• Which languages does James Colanero speak? 

  James Colanero speaks the following languages:
  No languages available.

• Which industries has James Colanero previously worked in?   

  James Colanero has prior experience in the following industries:
  Vertex Pharmaceuticals , Medicago , The Janssen Pharmaceutical Companies Of Johnson And Johnson , Merck , Merck , Merck

• What is James Colanero’s work experience?  

  James Colanero has the following professional experience:
  Biomarin Pharmaceutical , Vertex Pharmaceuticals , Medicago , The Janssen Pharmaceutical Companies Of Johnson And Johnson , Merck , Merck , Merck .

• How can I find James Colanero on LinkedIn?  

  You can view James Colanero’s
  LinkedIn profile at LinkedIn URL.

• What are James Colanero’s work email addresses?  

  James Colanero’s work email addresses are
  [email protected] .

• What company does James Colanero work for?  

  James Colanero works at
  Biomarin Pharmaceutical