10+ years validation and quality service experience
Project management of fda regulated projects
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.
Candidates must demonstrate a passion for the Life Science industry with extensive operational and engineering experience in FDA-regulated environments.
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 quality service experience
Project management of FDA regulated projects
Knowledge of cGMP and FDA validation methods
Experience leading CQV project teams
Working knowledge of GAMP methodologies
Nice-to-have
Client development and business building experience
Entrepreneurial spirit in consulting environment
Experience with process automation concepts
Strong leadership and mentorship capabilities
Ability to travel for project installation
Key Requirements
BS Degree in Engineering or related technical degree
15+ years Life Science operational & engineering experience
10+ years experience in validation/quality service and project management
Demonstrated client development experience
Experience creating proposals and business development