Product Manager, Quality Systems Job Summary
As a Product Manager, Quality Systems, you will lead upgrades to IT systems for Quality and Supply Chain departments in a regulated environment.
The ideal candidate will have proven experience in managing stakeholders and navigating complex business environments.
* Lead remediation & upgrade projects on legacy systems to bring them in-line with current technologies.
* Manage projects across QA, QC, Production Quality Systems, and Supply Chain functions.
* Migrate systems, introduce new technologies, analyze cyber risks, and assess application risk.
* Collaborate with high-level IT Architecture Teams, Cyber Security, Technical Support, and other teams within the organization.
Requirements
To succeed in this role, you will need:
* A Bachelor's Degree in Computer Science or STEM Majors (Science, Technology, Engineering, and Math) or equivalent.
* Strong relevant professional experience in working in the Pharma or IT Industry, including experience in the Digital Lab domain.
* Technical experience with Quality platforms such as LIMS (Lab Information Management System), Chromatography systems (Chromeleon, Empower), Environmental Monitoring, and Quality Management systems is mandatory.
* Expert understanding of analysis & design and system architecture concepts.
* Expert knowledge of CSV lifecycle with understanding of Gx P (GLP/GCP/GMP), 21 CFR Part 11, EU Annex 11.
* Ability to execute in a technical environment and willingness to engage and understand technical solutions, challenges, and issues.
Preferred Qualifications
We are looking for candidates with:
* Drug development experience.
* Ability to break down problems, build requirements for development tasks in an agile manner.