Base: $160k - $230k; bonus/equity: not specified; ...
15+ years life science operational experience
10+ years validation and quality service experience
Fda regulated project management expertise
This role involves leading a Regulatory Compliance Validation team for pharmaceutical, biotech, and medical device manufacturing projects in the Southern California Area
Job Summary
This role involves leading a Regulatory Compliance Validation team for pharmaceutical, biotech, and medical device manufacturing projects in the Southern California Area.
The successful candidate will leverage past professional experiences to expand the firm's presence in the Life Science market sector while delivering high-quality solutions to clients.
Design Group fosters an environment of mutual respect and unconditional interest in individual success, offering professional development resources including mentorships and career path tools.
Matching Summary
This role involves leading a Regulatory Compliance Validation team for pharmaceutical, biotech, and medical device manufacturing projects in the Southern California Area.
Salary
Base: $160k - $230k; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
15+ years Life Science operational experience
10+ years validation and quality service experience
FDA regulated project management expertise
cGMP and GAMP methodologies knowledge
21 CFR Part 11 compliance understanding
Clean utilities and bioprocess systems qualification
Nice-to-have
Client-side and consulting experience preferred
Entrepreneurial spirit and leadership mindset
Experience building long-term client relationships
Ability to mentor and develop teams
Passion for industry-leading best practices
Key Requirements
BS Degree in Engineering or related technical degree
15+ years of Life Science operational & engineering experience
10+ years' experience in validation/quality service and project management
Demonstrated client development experience
Project Management experience in scope, cost, schedule, quality, and risk