Business Development Director-Validation
Core
Lead a Regulatory Compliance Validation team to deliver solutions for pharmaceutical, biotech, and medical device manufacturing clients in the Life Science sector.
Role type
Senior IC Business Development Director / Client Development Lead (Validation & Regulatory Compliance)
Builds
Regulatory compliance validation solutions for clean utilities, facility systems, and process support systems
Domain
Life Sciences (Pharmaceutical, Biotech, Medical Device) + Engineering Consulting
Deliverable
client delivery
Required skills
Validation and regulatory compliance expertise, project management, team leadership, client development, proposal creation, budgeting, cGMP knowledge, FDA validation methods, data integrity concepts
Preferred skills
Experience with commissioning and qualification of bioprocess manufacturing systems, GAMP methodologies, 21 CFR Part 11 compliance
Technologies
Project management tools, word processing tools
Responsibilities
Lead a Regulatory Compliance Validation team for pharmaceutical, biotech, and medical device projects; meet with clients to define program requirements based on production process flow; assess project requirements and determine scope, budget, and staffing; coordinate technical requirements with engineering disciplines; prepare or review budgets; build and sustain long-term client relationships; participate in industry organization events and conferences.
Seniority
Senior, hands-on IC with leadership responsibilities
