Quality Assurance Manager (Computer System Validation)

Title – Quality Assurance Manager

Duration – 12 Months

Location – 100% Remote

Minimum Rate is $48 an hour

REMOTE : PST hours preferred (EST hours okay) - STANDARD 8-5

Candidates may need to work outside normal business hours on occasion, particularly once per quarter for system releases.

Ideal candidate :

Computer Systems Validation experience is mandatory. Ability to interpret and apply GMP, GLP, and GCP regulations. Validation and change control experience is required. Strong documentation, operational, and guideline compliance experience. No specific degree requirement – candidates with extensive Computer Systems Validation experience are acceptable regardless of their degree field. Strong communication skills (written and verbal). A team player who can collaborate effectively. Ability to handle escalations professionally and de-escalate conflicts. Must be proactive and engaged, rather than just following procedures passively.

Duties :

• Act as Quality Assurance (QA) contact for Change Control(s) for Computerized System activities
• Review and Approve validation deliverables (e.g. Validation Plan, Requirement Assessment, support Testing Protocols, Summary Reports, etc.)
• Change Agent and advocate for the Risk Based Validation program
• Able to act as SME for multiple Quality processes (e.g. Deviations, CAPA)
• Review and Approve SOPs and associated documents
• Review / Approve Periodic Reviews for GxP Systems
• May perform software Supplier Evaluations as needed
• Support project initiatives, process improvements and or projects
• May be required to present on topics or issues to management
• May support audit & Inspections requests as needed
• May support other duties as required

Skills & Behaviors :

Preferred Qualification

Education :

Nice-to-Have :

Experience working with Veeva or Safety Systems is a plus, but not required.

Knowledge of industry-wide regulatory systems

Salary : $48