IVD QMS Compliance Manager - cGMP
Cytek Biosciences
Cytek Biosciences in Fremont is seeking a QMS Compliance Manager to lead the development and implementation of a compliant IVD cGMP Quality Management System. This role requires expertise in regulatory environments, process improvement, and team leadership. The ideal candidate will have at least 8 years in a GMP-regulated setting and a strong background in quality standards. Responsibilities include conducting audits, developing SOPs, and ensuring readiness for inspections. #J-18808-Ljbffr Cytek Biosciences
- ...cutting‑edge biotech company, this is your opportunity. Role Overview The QMS Compliance Manager is a hands‑on leader responsible for building, implementing, and sustaining a compliant, scalable IVD cGMP QMS across Cytek facilities. The role develops practical processes,...SuggestedShift work
$120k - $140k
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- ...customer service skills and experience in research regulatory compliance, specifically with review boards: institutional review boards... ...reviews of human subject and animal subject protocols, including management of Institutional Review Board (IRB) committee, Institutional...Work at officeRemote workFlexible hoursNight shift
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...including first pass yield, failure Pareto, and retest rate, and translating data into actionable corrective actions for engineering and management reviewStrong written communication skills with the ability to produce technical briefs and status summaries with minimal...Full timeContract work$140k - $155k
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Job Summary The Manager, Quality Control (QC) - Analytical is responsible for leading and... ...leadership, technical expertise, regulatory compliance, and biosecurity oversight to support... ...personnel are fully trained and qualified in cGMP practices, analytical techniques, and...Contract workLocal areaFlexible hours- Overview Workday Testing Lead — Experience: 10-12 years Skills: All modules Job Description: Manages testing activities for Workday implementations. Responsibilities Develop test strategies and scripts. Coordinate UAT, regression, and end-to-end testing. Mentoring & Leadership...
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...Operations ManagerThe Operations Quality Manager will manage the Quality Operations team and... ...alignment with corporate goals and compliance with all regulatory requirements for Philips... ...1CFR (803, 806, 820, etc.), MDD/ EU MDR, cGMP, and GDP.You have proven experience utilizing...Full timeWork at officeImmediate startWork visaRelocation package3 days per week
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