Onsite Business Development Director

Posted 1 hour ago

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About the role

  • Director of Compliance & Validation at Design Group leading capital projects in life sciences. Supporting clients in regulatory compliance with a team of validation professionals.

Responsibilities

  • You'll work individually and in teams to support capital projects and implement solutions for our clients
  • Together, you will help our clients make critical changes to improve their performance and realize their most important goals
  • Lead a team of validation professionals and interface with clients
  • Provide subject matter expertise in the validation of a variety of utility, facility, and process equipment
  • Develop project scope statements, estimates, and proposals
  • Lead regional business development efforts and expand engagements with existing clients
  • Work on multiple projects simultaneously
  • Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team

Requirements

  • A minimum of ten years of experience with increasing responsibility in validation/quality service and project management of life sciences, biotech, or other FDA regulated projects
  • Project management experience involving scope, budget, schedule, quality, risk, and client management
  • Diverse experience leading CQV project teams related to the commissioning and qualification of clean utilities, facility systems, process support systems, bioprocess manufacturing systems, packaging equipment, and process and cleaning validation (preferred)
  • The ability to read engineering documents and experience in proposal development
  • A solid understanding of EPCMV, Quality by Design, and risk analysis methods including FMEA, HAZOP and Fault Tree Analysis (preferred)
  • An understanding of good documentation practices, cGMP, and FDA validation methods and systems
  • A working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance, and the latest industry expectations for data integrity
  • Strong project management software and word processing skills, and solid technical writing skills
  • A passion for a career in the life science industry
  • Experience in mentorship, multi-discipline collaboration, and in a consulting and service environment
  • A willingness to travel for project requirements including project installation and start-up activities, client and company sponsored meetings, trainings, industry related seminars, forums, and conventions
  • A bachelor of science in engineering or a related technical degree.

Benefits

  • Professional development resources
  • Mentorship programs
  • Flexible work arrangements

Job title

Business Development Director

Job type

Experience level

Lead

Salary

$150,000 - $200,000 per year

Degree requirement

Bachelor's Degree

Location requirements

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