Project/Program Management

Our talented Project and Program Managers have extensive experience in all aspects of operations and improvement initiatives for our pharmaceutical, biotech, and medical device clients.

Our Program Managers embed into your organization to make sure that all aspects of the program are addressed and monitored through completion, from program charter, organizational structure, management updates and presentations, and financial analytics to ensure consistent delivery and full transparency.

Examples of the types of programs we have managed for clients are:

  • New Facility C&Q
  • Validation PMO
  • Quality System Remediation
  • Contingent Staff Management
  • Capital Projects Management
  • Vendor Management
  • Budget and Schedule Management
  • Facility Retrofit and Expansion Projects

Many of our clients also utilize our Project Managers to oversee individual project streams within larger program initiatives to take advantage of synergies, consistent methodology, and accountability.

Our PMP Certified Project Managers create detailed project plans to define and manage the following aspects of a project:

  • Stakeholder Expectations
  • Project Scope
  • Project Schedule
  • Project Resources
  • Project Cost
  • Project Quality
  • Project Risk
  • Project Communications

Some of our recent projects...

  • IT System CSV Remediation
  • Quality System Remediation
  • CMMS Implementation
  • Warehouse Construction
  • Facility Refresh
  • C&Q for a New Autoimmune Therapeutics Facility
  • C&Q of Two New Sterile Fill & Finish Facilities Supporting Manufacture of COVID-19 Vaccines
  • Multiple Major Cleaning Validation Projects
  • Multiple Data Integrity Projects
  • Multiple Computer System Validation Projects
  • Development of QMS and Execution of C&Q Activities for Large Scale Ethanol Facility to Meet FDA and EU Regulations