FAQ About Robert Culmo

• What is Robert Culmo's address?

  Robert Culmo is located at
  Madison, Connecticut, United States

• What is Robert Culmo's job title?

  Robert Culmo is a A proven leader in team-oriented environments. Demonstrated success in building and directing Computer System Validation (CSV) and Quality Assurance teams with a “Patient First” mentality. Mentored and coached these teams for success. Instilled in these teams that Quality must be “Built-Into” systems. Overhauled underperforming teams/team members by determining the root cause of the issues and correcting them. Mentored and coached new and inexperienced team resources. Deftly identified and implemented risk-based initiatives to spur Quality Management process and performance improvements based on best practices. A customer focused, proactive, and self-motivated individual with a history of working cross-functionally in a matrix model. Outstanding communicator and presenter, engaging with executive leaders and global and site CSV and Quality teams to coordinate execution of priority directives. A track record for attention to detail, logic, innovation, methods and process improvements to execute projects and solve difficult problems. CORE COMPETENCIES • Management of large multiple concurrent IT projects. • Agile project management advocating adaptive planning, evolutionary development, early delivery, and continuous improvement, encouraging rapid and flexible response to change. • Quality and CSV Team Development & Oversight • Manufacturing, R&D, Quality, and Clinical Supplies Development Business Acumen • Computer Science Background – M.S. degree. • Chemistry Background – B.S. degree. • Customer Focused/Relationship Builder. • Ability to anticipate and document project risks and successfully develop and drive risk mitigation plans with testing and Standard Operating Procedure (SOP) controls. • Overall IT systems risk assessments and remediation. Escalation of company risk concerns to upper management. • Results Oriented/Best Practice Philosophy • Working knowledge of current federal GxP (GCP, GLP, GMP), 21 CFR Parts 11, 210, 211, 312, 314, 820, 1306, 1311 and state regulations. • Working knowledge with EMEA, EudraLex vol. 4, EU Annex 11, SOX, ICH (Q7, Q8, Q9, and Q10), ASTM E2500, ISO 13485, and ISO 9001. • Directed the team to use the “Computer Software Assurance (CSA) approach” to support risk-based CSV GXP projects. • Directed the team to work with software developers and business experts to break up work into sprints with brief daily project standup meetings to deliver workable and tested software at the end of every sprint.

• What industry does Robert Culmo currently work in?

  Robert Culmo currently works in the Alexion Pharmaceuticals |

• Which languages does Robert Culmo speak?

  No Languages Available

• Which industries has Robert Culmo previously worked in?

  Robert Culmo has prior
  experience in the following industries:
  

• What is Robert Culmo’s work experience?

  Robert Culmo has the following professional experience:
  Alexion Pharmaceuticals | Rc Const | Pfizer | Baldinis Sports Casino | Catalent Pharma Solutions | Forest Laboratories | Alku

• How can I find Robert Culmo on LinkedIn?

  You can view Robert Culmo’s LinkedIn profile at LinkedIn URL

• What are Robert Culmo’s work email addresses?

  Robert Culmo’s work email
  addresses are
  robert.culmo@catalent.com

• What company does Robert Culmo work for?

  Alexion Pharmaceuticals |