This role leads a Regulatory Compliance Validation team for pharmaceutical, biotech, and medical device manufacturing projects within the Life Science market sector
Job Summary
This role leads a Regulatory Compliance Validation team for pharmaceutical, biotech, and medical device manufacturing projects within the Life Science market sector.
The successful candidate will leverage past professional experiences to expand presence in New Jersey while delivering high-quality solutions to clients facing complex regulatory challenges.
Join a rapidly growing organization of over 1,500 professionals united by a belief to use the power of business to build a better world through truly human leadership.
Matching Summary
This role leads a Regulatory Compliance Validation team for pharmaceutical, biotech, and medical device manufacturing projects within the Life Science market sector.
Skills & Requirements
Must-have
15+ years Life Science operational experience
10+ years validation and project management
cGMP and FDA validation methods expertise
Clean utilities and facility systems commissioning
Process automation and computer system validation
GAMP methodologies and 21 CFR Part 11 compliance
Nice-to-have
Client development and business building experience
Entrepreneurial spirit and leadership mindset
Experience with bioprocess manufacturing systems
Strong presentation and communication skills
Ability to mentor and develop team members
Key Requirements
BS Degree in Engineering or related technical degree
15+ years Life Science operational & engineering experience
10+ years increasing responsibility in validation/quality service
Experience leading CQV project teams
Project management experience in scope, cost, schedule, quality, and risk