Quality Assurance Manager (CSV, GMP, GLP, GCP, Deviations, CAPA, Change Control, validation and Risk) Pharma/Biotech
Job Title: Quality Assurance Manager
Location: Nashville, TN/Remote
Duration: 6+ Months with possible extension
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.
Top 3 Must Have Skill Sets:
• 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
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Location: Nashville, TN/Remote
Duration: 6+ Months with possible extension
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.
Top 3 Must Have Skill Sets:
• 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
Apply tot his job
Apply To this Job