IVD QMS Compliance Manager - cGMP & Audits
Cytek Biosciences Inc
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 a hands-on leader with extensive experience in GMP regulations and an ability to drive organizational change towards a compliant cGMP environment. Applicants should have a relevant degree and 8+ years of experience in a GMP-regulated setting. #J-18808-Ljbffr Cytek Biosciences Inc
$131k - $165k
...an accommodation or an alternative application process. QMS Compliance Manager - IVD cGMP Full Time Fremont, CA, US 6 days ago Requisition ID: 116... ...non‑GMP to full cGMP operations, ensuring readiness for audits and long‑term regulatory compliance. ESSENTIAL DUTIES AND...SuggestedFull timeShift work- 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... .... Responsibilities include conducting audits, developing SOPs, and ensuring readiness for...Suggested
- 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...SuggestedWork at officeFlexible 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$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...SuggestedFull timeWork at office- ...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...
- ...impact Job Description: The Clinic Manager for the Health Access Point (HAP)... ...to-day administrative, operational, and compliance oversight of the HAP clinic. This role ensures... ...for operational issues related to audits, inspections, or compliance reviews Monitor...Local area
$150k - $180k
Allogene Therapeutics is seeking a Senior Manager, QC Raw Materials to oversee the raw materials management program at our Newark, CA facility. This role includes responsibilities for inspection, sampling, and testing of raw materials, requiring a proactive approach to...$104k - $231k
...Within the Global Products Group, the Product Regulatory Compliance Organization is dedicated to the successful implementation and... ...portfolio throughout the product lifecycle. As a Technical Program Manager at Lam, you will lead cross-functional regulatory compliance...Local areaRemote workFlexible hours2 days per week3 days per week1 day per week$120k - $140k
...JOB TITLE: Test Engineer Manager TYPE: Full-Time/Exempt LOCATION: Fremont, CA (Onsite) SALARY: $120,000-$140,000 Job Summary: The Test Engineering Manager oversees the overall operations of the Test Development Engineering team, including technical...Full time- A leading technology firm in California is seeking an experienced Workday Testing Lead to oversee testing activities for Workday implementations. The ideal candidate has 10-12 years of experience and is proficient in all Workday modules. Responsibilities include developing...
- Minimum Qualifications Bachelor's degree in Electrical Engineering or a related field, or equivalent practical experience. 10 years of experience in silicon validation and testing. 5 years of experience in technical leadership with/without direct reports. Preferred ...
- 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...
- ...requirements and guidelines. Monitoring and reporting any issues related to production, safety, and employee relations to the management team. Troubleshooting test operation problems, including those related to material, employees, processes, and machines. Qualifications...Work experience placementImmediate start
- Duties/Responsibilities Supervise and manage a test operations team of approximately 35-50 employees, including Leads and Operators. Organize and adjust labor and equipment resources to ensure mass production projects (approximately 3‑5) meet production capacity requirements...Temporary workShift work
$240k - $334k
...Excellent problem‑solving/investigative skills, with communication and teamwork abilities. About The Job In this role, you will manage post‑silicon validation specification and execution. You will also be responsible for post silicon validation specification and execution...Full time- ...photonic systems. Responsibilities include collaboration with cross-functional teams, ensuring the effectiveness of testing, and managing personnel. This full-time role offers hybrid working arrangements within a stable and innovative environment. #J-18808-Ljbffr II-VI...Full time
- SOS Meals on Wheels is hiring a Grant Administrator responsible for managing and organizing the grant portfolio, ensuring grant compliance, and serving as the main point of knowledge for all grant-related activities. You will work closely with the Development team and...
$120k - $160k
...Technically lead and support cybersecurity test audits from external and internal parties Be... ...reasonable duty as directed by the line manager Skills / Qualifications Relevant... ..., vulnerability management, and compliance for EU market access Confident ability...- ...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...
$190k - $250k
...performing and field‑proven optical solutions from components, modules to integrated line‑cards. We provide cutting edge wavelength management and amplifier technologies. Our comprehensive optical, mechanical, electrical and software integration capabilities enable us to...Flexible hours- ...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...
$230k
...Director, Regulatory Affairs Manages all regulatory activities for the company. Develops... ...with project teams to ensure regulatory compliance throughout the product development and... ..., DSUR, PSUR, REMS Annual Reports and audits), product approval process, and post-market...- A leading semiconductor solutions provider is seeking a Senior Technical Program Manager to lead cross-functional teams and oversee semiconductor test systems development. The ideal candidate should have over 10 years of experience in technical program management within...
- ...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...
- ...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
$159k
...Job Category: Business Operations / Strategy; Compliance / Risk / Quality Assurance Job Level: Senior Manager Business Unit: Strategy & Growth Work Type:... ...dashboards. Ensure documentation, records, and audit trails support regulatory requirements and external...Work experience placementWork at officeFlexible hours$159k
...Operations / Strategy Job Level: Senior Manager Business Unit: Strategy & Growth... ...Department Overview: The Electric Risk & Compliance organization provides governance,... ...rhythms; and ensuring documentation and audit trails support regulatory requirements....Contract workWork experience placementWork at officeFlexible hours2 days per week3 days per week- ...as championing Moximed’s total quality management system for orthopedic implants and single... ...assurance, quality control, regulatory affairs, compliance, and post-market surveillance. They will... ...action. Supervise and manage internal audits and inspections including FDA, Cal FDB...
$143k - $209k
...About our group: The SOX Program Management Office (PMO) is the central team responsible... ...the company's Sarbanes Oxley (SOX) compliance program. We coordinate SOX scoping, planning... ...controls are executed, documented, and audit ready. Acting as the primary liaison with...Full timeTemporary workWork at officeLocal areaFlexible hours3 days per week
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