Manager, Quality

San Diego, CA

  • Samumed is looking for a highly motivated Manager, Quality to join its Quality Assurance team.
  • This position will be based in Samumed’s San Diego office. 

Specific Responsibilities

  • Implement and maintain document control, training management, and quality management processes and systems to ensure GxP compliance with internal policies and external regulations
  • Manage document control (EDMS), training management (LMS) and quality management (QMS) processes and systems for GxP activities in compliance with internal procedures and policies as well as with regulatory requirements
  • Manage the routing, review, approval, distribution and archiving of new and revised controlled documents
  • Ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedures
  • Manage GxP Records Retention schedule
  • Identifies and implements document control process improvements to ensure compliance
  • Maintain training matrix and curricula- create, and manage training courses in LMS
  • Manage periodic review of procedures and training events
  • Collaborate with cross-functional team members to author and revise controlled documents
  • Support periodic audits to ensure regulatory compliance during external and internal audits
  • Provides support during regulatory inspections
  • Prepare status reports for Document Control, training, and quality systems for Quality management review
  • Participate and support in validation activities for change controls, CAPA and releases
  • Perform new hire orientation and training on the LMS
  • Perform data-entry and reconcile legacy and active training files
  • Business administration of EDMS, LMS and QMS
  • Other duties as assigned

Requirements

  • Bachelor's degree or a combination of relevant education and applicable job experience may be considered. Minimum of 3 years’ experience within FDA regulated industry including:
  • Experience working with Electronic Documentation Management Systems (EDMS), Learning management system (LMS) and Quality Management System (QMS)
  • Experience with Veeva Vault-Quality Docs, Training and QMS module preferred
  • Direct experience developing and maintaining document control, training management and quality management systems
  • Knowledge of ISO, FDA, GDP, and cGMP concepts and guidelines
  • Excellent computer skills, writing and editing skills with strict attention to detail to meet compliance requirements
  • Works on multiple assignments in collaboration with cross functional team members

Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.