Drives departmental projects to completion through providing leadership and management to all personnel and functions involved.
Management of projects to meet appointed timelines and achievement of required completion dates, including large scale Quality initiatives in new technologies to improve efficiency.
Assists and supports department in routine functions to include but not limited to deviation investigations, CAPA processing, and customer complaint investigations as needed.
Perform review and approval tasks for the department as needed.
Identification of project scopes, required resources, resource assignment and management.
Responsible for monitoring and updating project status and communicating this information to management.

Bachelor of Science degree in Engineering, Biology, Chemistry, Biochemistry, Information Systems or closely related scientific/technical discipline is required.
Minimum of 5 years direct Quality experience in a pharmaceutical, GMP, or FDA regulated environment is required.
Minimum of 3 years experience in SAP and Microsoft Access
Computer proficiency in MS Office (Teams, Outlook, Word, Excel, PowerPoint).
Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
Must have strong technical writing skills.
Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.

Project Manager – QA

Key skills