Sr Manager, Document Control

Sr. Manager, Document Control:

• To develop strategy, structure, tooling and organization around document and process control for our clinical programs, quality management system and operation functions.
• To work closely with Technical Operations and R&D teams to support new product introduction, production batch records change control and BOM setups with CDMO.
• Lead and manage the document control department, including management and processing of manufacturing change requests and ensure adherence for good documentation practices and record retention policies.
• QA lead for managing the QMS flow for Deviations, NCR, CAPA, etc.
• Manage documentation archive of product design history files, validation protocols, plans and reports, and production records. Ensure all document control processes and retention of records are in compliance with applicable QMS standards. • Create training contents for document related quality management processes.
• Oversee part number creation and revision change of items.
• Create and track Key Performance Indicators of the CDMO.
• Ensure proper document and record management resourcing are established to support the growth of the company.

*This person will need to be located in San Diego!