Responsible for planning and leading change control implementation for multiple projects across global product quality.
More specifically they will be managing (and owning as needed) documentation and change controls associated with key deliverables to clinical and commercial documentation across multiple programs.
Provide quality oversight and keep track of multiple work streams and collaborate across multiple functions (i.e. Site QA/QC, manufacturing, validation, IT, manufacturing science and technology, analytical development, etc.) to ensure all technical and compliance requirements are met per clinical and commercial development timelines.
Follows-up to verify completion of activities.
Provides assistance to other Global Product Quality staff members
BA or BS degree.
Minimum of 5-7 years of demonstrated success implementing complex business or technology initiatives.
Minimum of 3 years working under GMP conditions..
Experience with owning change controls is required.
Scientific background with basic understanding of typical analytical methods and Quality Control
Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products.
Detail oriented with high degree of focus.
Able to follow instructions and procedures, both written and verbal.
Able to understand complex work practices.
Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
Strong written, verbal, and organizational skills, and ability to work in inter-disciplinary and cross-functional teams.
Able to perform with minimal supervision and contribute in a team environment.
Basic knowledge and ability in using Microsoft Office Package.
Experience with eQRMS, electronic documentation systems (Veeva), and other quality systems is preferred