A rapidly expanding pharmaceutical company, is looking to onboard a QA Senior Manager of Document Control.
In just six months, the company went from being in Pre-clinical / Phase 1 stages to several therapies in their pipeline reaching Phase 3. Because the company is nascent, you will have unlimited opportunities for professional growth at a senior level. Currently, their leading candidate is a cancer treatment with FDA Fast Track Designation.
The company is specifically seeking a candidate that has extensive experience with Document Control, as much of the role is digitizing documents.
Location: San Diego, California
Compensation: Commensurate with experience
WFH Policy: Potential for hybrid schedule
- Receive, file, and maintain all GxP documents
- Assist in the selection and implementation of an eQMS
- Manage a Document Repository
- Maintain GxP audit files and assist with entry, tracking, and archiving of audit record
- Maintain overall document control structure within the document management system
- Bachelor's degree in Science or similar field preferred OR Associate's degree & experience
- >4 years of experience in a regulated environment and experience in managing and administering document control systems.
- Knowledge of quality systems & regulatory compliance requirements in pharma or biotech
- Excellent interpersonal skills