New 
Quality Assurance Manager
 Spectraforce Technologies | |
 United States, Tennessee, Nashville | |
 Apr 02, 2026 | |
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Position Title: Quality Assurance Manager
Work Location: Remote Assignment Duration: 06 Months(Possibility of Extension) Work Schedule: 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. Position Summary: 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. Key Responsibilities: * 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 Qualifications & Experience: * Validation and Change Control experience (Highly preferred: Risk Based Validation experience and or strong Computer System Assurance (CSA) knowledge) * Strong organizational skills, including ability to follow assignments through completion. * Initiate and lead cross functional teams as needed * Collaborate and communicate with higher level outside resources. * Strong communication (both written and oral), facilitation, and presentation skills. * Strong skill in working independently and to effectively interact with various levels of management * Ability to lead and influence staff outside QA organization * Able to manage performance issues and conflict * Ability to evaluate documentation/ operations according to company and regulatory guidelines * Ability to interpret and apply GMP, GLP, GCP, GPvP regulations Preferred Qualification * 5+ years' experience in a regulated industry in a similar role (e.g. Biotechnology, Medical Device, Aerospace) * Demonstrated strong Knowledge of industry and business principles * Demonstrated strong problem-solving abilities and strong risk assessment capabilities Education: * Master's degree in technical or related subjects and 3 years with direct experience * Bachelor's degree in technical or related subjects and 5 years with directly experience * Will consider those that have significant years of direct experience in lieu of education requirements | |