Title: Senior QMS Manager

Location: Redwood City, CA

Employment Type: FTE or Contract to Hire

Workplace Type: Hybrid

Reports To: Executive Director, Quality

Subject Matter Expert (SME) of Quality Management System (QMS) processes including:

• Controlled Document Management
• Learning Management (Training)
• Deviation/Event Investigation
• Corrective and Preventive Action (CAPA)
• Change Control and Management
• Product Complaints
• Audits and Inspections

Responsibilities and Duties

·      Provides quality systems services to Celito Tech, Inc. clients to include vendor qualification, Computerized System Validation (CSV) oversight, and project management.

·      Coordinates and communicates with clients and vendors to determine best fit for QMS technology solutions. Defines QMS processes based on industry best-practices and documents requirements for computerized system selection and development.

·      Plans and implements software development and/or IT hosting vendor qualification via questionnaire, documentation review and Auditing.

·      Works with clients and vendors to implement, validate and maintain computerized systems supporting Quality, Manufacturing, Clinical, and Regulatory operations. Provides QA review of CSV deliverables to ensure GxP and IT compliance.

·      Supports development of client and Celito QMS policies, procedures, and work instructions for administration and use of computerized systems. Provides SME input and training for QMS processes and computerized system use.

·      Assists with implementation and management of client and Celito QMS processes and computerized system business administration (e.g., document control, training coordination, incident/change management).

·      Assists clients and Celito with audit/inspection readiness including standard operation procedure (SOP) preparation, mock audits/inspections and “back room” coordination. Supports and participates in QMS audit/inspection responses and CAPA development.

·      Identifies areas within client Quality and IT departments where Celito can provide assistance and support. Communicates and coordinates between Client and Celito to define needs and manage engagements.

·      Contributes to Celito QMS software development including process definition/design, system review and development testing for functionality and User Interface (UI) as well as validation, training and system support documentation.