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. The QMS Compliance Manager is a hands-on leader and change agent responsible for building, implementing, and sustaining a compliant, scalable IVD cGMP Quality Management System (QMS) across Cytek facilities. This...SuggestedShift work
- ...Cytek Biosciences Inc is seeking a QMS Compliance Manager to lead the implementation of a compliant, scalable IVD cGMP Quality Management System. Responsibilities include developing SOPs, overseeing internal audits, and supporting FDA compliance activities. This role requires...Suggested
$133k - $189k
...SUMMARY/JOB PURPOSE: The Compliance QA Manager, QA Core, is responsible for coordinating and maintaining inspection readiness activities and provides support for assessing proposed corrective and preventive actions in response to inspection findings. This role supports...SuggestedContract workWork at officeLocal areaFlexible hours$230.45k - $275k
...quality control processes for drug products, requiring a PhD and 7+ years of relevant experience. The ideal candidate will ensure compliance with regulatory guidelines and supervise various analytical methods. The position offers a competitive pay range of $230,447 - $2...Suggested- ...place to make a meaningful impact Job Description: The Clinic Manager for the Health Access Point (HAP) Program is responsible for the day-to-day administrative, operational, and compliance oversight of the HAP clinic. This role ensures that clinic operations run...SuggestedLocal area
$104k - $231k
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...ECMS operates globally in 15 countries with approximately 20 production sites and over 4,000 employees. As a Quality Assurance Manager you will LEAD by.......... Managing the activity of the quality assurance department developing, implementing, and maintaining...Permanent employmentFlexible hours$124.5k - $177k
...SUMMARY/JOB PURPOSE: Responsible for managing and maintaining existing Investigational New Drug (IND), Clinical Trial Application (... ...Licensing Application (BLA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and...For contractorsLocal areaFlexible hours- NOW HIRING: Quality Manager | Advanced Manufacturing Environment We are seeking an experienced Quality Manager to lead and strengthen... ...role focused on driving operational excellence, regulatory compliance, and continuous improvement across manufacturing and quality operations...Temporary workImmediate start
- ...requires 15+ years of experience in medical device quality assurance and strong leadership skills. The successful candidate will manage compliance with FDA regulations and direct quality initiatives. Candidates with experience in orthopedic medical devices will be...
- ...NDAs Provide strategic regulatory guidance on CMC development plans, comparability strategies, process changes, and lifecycle management Act as primary CMC regulatory liaison with global health authorities, including FDA and EMA Partner closely with Process Development...
$145k - $230k
...deliver cohesive system test solutions. Lead design and architecture reviews to ensure robust and manufacturable test systems. Manage the personnel necessary to develop testing and perform such testing in development and manufacturing. Cross-Functional...Full timeWork at office$159k
...Category: Business Operations / Strategy Job Level: Senior Manager Business Unit: Strategy & Growth Work Type: Hybrid Job... ...; Yuba City Department Overview: The Electric Risk & Compliance organization provides governance, oversight, and strategic direction...Contract workWork experience placementWork at officeFlexible hours2 days per week3 days per week- ...HIGH-LEVEL OVERVIEW The Director, Trade Compliance is responsible for leading the strategy, governance, and execution of the global trade... ...ECCN and HTS classification, export licensing, and license management · Manage denied party screening programs and deemed export controls...
$230k
...Job Summary Manages all regulatory activities for the company. Develops and implements regulatory strategies for internal product... .... Collaborate with project teams to ensure regulatory compliance throughout the product development and product lifecycle. Direct...- ...libraries to bring in efficiencies. Experience with Jira or similar Agile process tools. Experience with using defect management and test management tools. Excellent SQL knowledge with the ability to write complex queries for validation as well as review...
- ...SAP Test Manager The manager for SAP Testing project is responsible for the overall delivery of SAP Testing project. This role is based out of Newark, CA and will involve working with people and teams across geographies. Core Responsibilities: Define and enforce...
- ...SAP Test Manager Newark, CA (Hybrid) The manager for SAP Testing project is responsible for the overall delivery of SAP Testing project. This role is based out of Newark, CA and will involve working with people and teams across geographies. Core responsibilities include...
$177.5k - $251.5k
...timely fashion, and aligning metrics that provide input into a compliance scorecard for Clinical programs. This leader provides insight... ...partners with both GCP QA staff and Clinical Operations Quality Management (OQM) to address day-to-day clinical trial operations...Local areaFlexible hours$159k
...Requisition ID # 172683 Job Category: Business Operations / Strategy; Compliance / Risk / Quality Assurance Job Level: Senior Manager Business Unit: Strategy & Growth Work Type: Hybrid Job Location: Oakland; Alameda; Alta; American Canyon; Angels Camp;...Work experience placementWork at officeFlexible hours- ...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
$248k - $352.5k
...g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance and alignment with study objectives and... ...Entry into Job: Knowledge/Skills: Develops and manages plans, establishes timelines, sets standards for performance....Contract workWork at officeLocal areaFlexible hours- This role owns the company’s quality management system, ISO / QMS calendar including activities, audit, and process compliance. The position works cross-functionally with functional managers to help ensure adherence to company procedures, quality standards, and regulatory...Work at officeFlexible hours
$143k - $209k
...About our group: The SOX Program Management Office (PMO) is the central team responsible for managing and governing the company's Sarbanes Oxley (SOX) compliance program. We coordinate SOX scoping, planning, testing timelines, evidence management, and auditor interactions...Full timeTemporary workWork at officeLocal areaFlexible hours3 days per week- ...regulatory strategies for orthopedic implants. This role involves guiding the quality management system, overseeing regulatory submissions, and managing cross-functional teams to ensure compliance. The ideal candidate will have over 15 years in the field, excellent knowledge...
- A city government organization in Fremont is seeking a Quality Assurance Senior Program Coordinator to oversee quality assurance activities for behavioral health programs. This role involves conducting audits, developing training programs, and maintaining strong community...
- ...regulatory function, as well as championing Moximed’s total quality management system for orthopedic implants and single-use instruments.... ...of quality assurance, quality control, regulatory affairs, compliance, and post-market surveillance. They will also guide the regulatory...
- ...of quality experience in a regulatory environment. The supervisor will promote quality awareness, define procedures, and ensure compliance with food safety regulations. This full-time position offers opportunities to contribute to meaningful work that impacts the lives...Full time
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