Quality Assurance Manager

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 activitiesReview 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 programAble to act as SME for multiple Quality processes (e.g. Deviations, CAPA)Review and Approve SOPs and associated documentsReview/Approve Periodic Reviews for GxP SystemsMay perform software Supplier Evaluations as neededSupport project initiatives, process improvements and or projectsMay be required to present on topics or issues to managementMay support audit & Inspections requests as neededMay 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 neededCollaborate 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 managementAbility to lead and influence staff outside QA organizationAble to manage performance issues and conflictAbility to evaluate documentation/ operations according to company and regulatory guidelinesAbility to interpret and apply GMP, GLP, GCP, GPvP regulations Preferred Qualification5+ years' experience in a regulated industry in a similar role (e.g. Biotechnology, Medical Device, Aerospace)Demonstrated strong Knowledge of industry and business principlesDemonstrated strong problem-solving abilities and strong risk assessment capabilities Education:Master's degree in technical or related subjects and 3 years with direct experienceBachelor's degree in technical or related subjects and 5 years with directly experienceWill consider those that have significant years of direct experience in lieu of education requirements

Created: 2026-04-04