Title: Corporate Quality Lead
Summary: A global biotech leader is currently seeking an organized and self-driven Corporate Quality Lead to join their Massachusetts site. As an integral member of the Data Integrity and IT Quality team, this position will advise on the CSV for laboratory systems, ensure the compliance of data management practices, and work cross functionally with stakeholders in QA/QC, R&D, IT, Engineering, and Vendor Management.
The Corporate Quality Lead will be responsible for…
- Managing project deliverables and timelines relating to GxP QA system inventory and validation
- Resolving continuous improvement issues regarding lab instrumentation for software validation and DI
- Maintaining quality systems including change control, CAPA, documentation, and investigations
- Writing, reviewing, and approving SOPs
- Identifying, reporting, and monitoring quality risks and gaps
The Corporate Quality Lead should have the following qualifications:
- Bachelor's degree
- 6+ years of Life Sciences industry experience
- Extensive knowledge of GxP and Performance Qualification activities on lab equipment
- Expertise in CSV, DI, and IT
- Proficient in Microsoft Office
If you're interested in this Corporate Quality Lead role, then please don't wait to apply!