Director, Compliance and Validation
Core
Lead a Regulatory Compliance Validation team for pharmaceutical, biotech, and medical device manufacturing projects, ensuring solutions meet FDA regulations and client production needs.
Role type
Director, Compliance and Validation
Builds
Regulatory compliance and validation solutions for life science clients
Domain
Life Sciences (Pharmaceutical, Biotech, Medical Device)
Deliverable
client delivery
Required skills
Validation and regulatory compliance expertise, project management, team leadership, business development, budgeting, cGMP knowledge, FDA validation methods, data integrity concepts, GAMP methodologies, 21 CFR Part 11 compliance
Preferred skills
Clean utilities commissioning, facility systems qualification, process support systems validation, bioprocess manufacturing systems validation, packaging equipment validation, process and cleaning validation
Technologies
Project management tools, word processing tools
Responsibilities
Meet with clients to define program requirements based on production process flow and space environmental needs; Assess project requirements, break into tasks, and determine scope, budget, and staffing; Assign and review work of project team; Prepare or review budgets based on project scope; Assist in team education and development; Innovate and improve design and service delivery methods; Build and sustain long-term client and internal relationships; Participate in industry organization events and conferences.
Seniority
Director, strategic leadership & hands-on management
