Manage the performance and professional development of ADME staff while overseeing department functions. Strong knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP.
Numbers & Facts
Location
Malvern, PA
Description
Manage performance and professional development of staff
Oversee day to day function of department area
Participate in evaluation and adaptation of new technologies as applicable
Work alongside senior colleagues to define strategies for business success and growth
Support Business Development in development of new and existing clients
Define and review Key Performance Indicators to identify opportunities for improvement
Participate in client and regulatory audits as required
Collaborate with internal teams to meet project deliverable
Standardize procedures and improve efficiencies
Oversee staff recruitment, training, and progression
Ensure employee adherence to regulatory compliance for data integrity and assigned SOPs
Review and author SOPs
Other tasks as assigned
BA/BS or higher with 10+ years experience; all experiences will be evaluated
Strong knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP
Able to mentor and develop staff
Able to work in a regulated environment
Able to work effectively and contribute within a team
Able to work with computer systems
Able to document clearly and communicate clearly
Experience in a regulatory environment
Manage the performance and professional development of ADME staff while overseeing department functions