Quality Assurance Lead - GMP/CLIA & Audits
CareDx
CareDx, Inc. is seeking a Quality Assurance Lead to partner across multiple functions and drive quality excellence in a CLIA, FDA and GCLP environment, supporting the ongoing growth of CareDx's product portfolio. You will implement and maintain quality system processes ensuring compliance across the lifecycle of our products. You will manage the EQMS, lead CAPA, supplier quality, audits, and risk management activities, and provide design control guidance for Laboratory Developed Test services. #J-18808-Ljbffr CareDx
- Structure Therapeutics in South San Francisco is seeking a Senior Director of GMP Quality Assurance to lead the global GMP QA strategy, ensuring compliance and overseeing quality operations. The successful candidate will have over 15 years of experience in quality management...Suggested
- ...South San Francisco, CA, seeks a Senior Manager, Quality Assurance, Quality Operations to oversee day-to-day GMP QA activities across Rigel's global CDMO network,... ...supporting commercial and clinical products. You will lead manufacturing readiness, batch disposition, change...Suggested
$112k - $140k
CareDx, Inc. is a leading precision medicine solutions company focused... ...transplant patients. As the Quality Assurance (QA) Lead, you will partner... ...processes that support CLIA, FDA, and GCLP regulatory requirements... ...Support GCLP compliance and audits. Participate in external and...SuggestedFull time- A leading biotech company is seeking a self-motivated GxP and Regulatory QA Lead to oversee compliance within clinical and non-clinical... ...The role requires at least 7 years of relevant experience in Quality Assurance within the pharmaceutical or biotechnology industry,...SuggestedFull time
- ...pipeline, by ensuring high-quality clinical supplies that... ...program timelines Lead complex global cross-... ...inspections and internal audits, and represent Quality... ...experience in Quality Assurance, production, testing of... ...global requirements for GMP (D, EU, US) is required...SuggestedFull timeTemporary workLocal areaWorldwide
$240k - $300k
...Summary:We are seeking a Senior Director of GMP Quality Assurance (QA) to serve as a senior quality leader responsible for developing, leading, and executing the global GMP QA strategy... ...QA team, provide strategic oversight of audits and inspections, and serve as a trusted...Contract work$240k - $300k
...Summary We are seeking a Senior Director of GMP Quality Assurance (QA) to serve as a senior quality leader responsible for developing, leading, and executing the global GMP QA strategy... ...QA team, provide strategic oversight of audits and inspections, and serve as a trusted...Contract work- CareDx, Inc. is seeking a QA Lead in Brisbane, CA to drive quality excellence across functions and ensure compliance with quality system regulations and... ...to work independently within a team, with exposure to CLIA, FDA, and GCLP processes and potential design control guidance...
- ...GxP and Regulatory QA Lead to join our fast-growing... ...overseeing and ensuring quality and compliance of... ...assignments, GxP (GLP/GCP/GMP) compliance and FDA 21... ...CAPA, change controls and audit management. Collaborate... ...experience in Quality Assurance/Quality Control roles in...Full timeWork at office
- CareDx is seeking a QA Lead to partner across functions and drive quality excellence for CLIA, FDA, and GCLP compliance. You will implement and maintain quality system processes, work with cross-functional teams, and guide Design Control for LDT services to embed quality...
- Hanwha Q CELLS America Inc. seeks a QA Audits & Controls Manager to perform independent post-execution validation of operational processes and vendor activities. This role identifies defects, trends, and control gaps before they impact customers, investors, or regulators...Work at office
- Insitro in South San Francisco is looking for a Director of Quality Assurance to lead the quality systems as they transition into clinical-stage operations... ...in biotech/pharma, excellent knowledge of GLP, GCP, and GMP regulations, and the ability to integrate quality into daily...
- ...Pharmaceuticals, Inc. is seeking a Senior Manager of Quality Assurance, Quality Operations to oversee day-to-day GMP QA activities for commercial and clinical... ...biotech, strong regulatory knowledge, and experience leading investigations, #J-18808-Ljbffr Rigel Pharmaceuticals...
$160k - $180k
...top-line data from our lead program expected later this... ...>>> Associate Director GMP QualityAs the Associate Director, GMP Quality, reporting to the Head... ...Agreements and support Supplier audits as necessary Interact... ...relate to GMP Quality Assurance Experience: Minimum of 8...Work experience placementWork at officeFlexible hours$190k - $240k
...for the Director of Clinical Quality Assurance role at BioSpace 1 day ago Be... ...Establish the study specific audit plan ensuring successful execution... ...experience in successfully leading assigned activities within... ...days ago Associate Director, GMP Quality Assurance Redwood City...Full time$160k - $180k
Olema Oncology seeks a Senior Manager, GCP Clinical Quality in San Francisco, CA to ensure compliance in clinical development. This hybrid... ...relevant experience. Key responsibilities include conducting audits and supporting regulatory inspections. Compensation ranges from...2 days per week- Rigel Pharmaceuticals, Inc. is seeking a Sr Mgr, QA, Q Systems & Product Complaints to lead the Product Complaint Management Program and serve as Quality System Owner for CAPA. The role includes supporting Pharmacovigilance interfaces, external providers, and Health Authority...
- ...Group LLC is seeking a QA Tester to join its Walmart Customer Care application team in San Bruno, CA. This role involves leading quality assurance testing for eCommerce applications, implementing test automations, and ensuring the software development lifecycle is optimized...
- Rigel Pharmaceuticals, Inc. seeks a Senior Manager, Quality Assurance, Quality Systems & Product Complaints to lead the Product Complaint Management Program and... ...readiness, Health Authority inspections, and partner audits to ensure regulatory compliance and drive...
- Rigel Pharmaceuticals, Inc. is seeking a Senior Manager, Quality Assurance Quality Systems & Product Complaints in the US. You will lead the Product Complaint Management Program, oversee Pharmacovigilance vendors, and act as the Quality System Owner for the CAPA program...
- ...autonomy to reach your goals.We are seeking an Audit Manager to join the Financial Services... ...expectations, ensure satisfaction, and lead change efforts effectivelyUnderstand and... ...field5+ years of progressive audit and/or assurance experienceCPAExperience with asset...Full timeLocal area
$140k - $190k
...work together every day. We lead with empathy, act with an owner... ...Summary:The Senior Manager, Quality Assurance (QA), will report to the Director... ....Review and approve GMP documentation such as master... ...internal and regulatory agency audits as required.Perform Person-in...Contract workFor contractorsWork experience placementFlexible hours$205k - $218k
...OpportunityAt our company, quality isn’t a hurdle to... ...for a Director of Quality Assurance to serve as a key architect... ...Oversight: Lead the quality lifecycle for... ...CROs/CMO/CDMOs. Perform audits for partners performing GLP, GCP, and GMP work to ensure they meet...Home officeFlexible hours3 days per week- ...responsible for activities that lead to, and maintain compliance to/with Cutera’s Quality Management System and... ...Cutera’s Quality Assurance department and... ..., ISO and other agency audits of our quality system.Lead... ...Maintain compliance with FDA, GMP/QSR, Manufacturing...
$89.8k - $170.5k
We are the leading provider of professional services to the middle market globally, our purpose... ...’s nowhere like RSM.RSM is looking for a Audit Manager to join our Insurance team. Our... ....Responsibilities: Provide timely, high quality client service that meets or exceeds...Full timeWork experience placementInternshipLocal area$152.9k - $210.2k
...execution, risk assessment, and release-quality reporting across complex imaging programs... ...preparing headcount and equipment budgets to assure adequate resources are in place. - Grow... ...produce high-quality defect reports and lead defect triage, root-cause investigation,...Full timeWork at officeLocal areaWorldwideFlexible hours- ...to reach your goals. We are seeking an Audit Manager to join the Financial Services... ...objectives and determine an audit strategy Lead multiple audit engagements and competing... ...~5+ years of progressive audit and/or assurance experience ~ CPA ~ Experience...Local area
- ...organization. What are you waiting for? Hit apply! Location: South San Francisco, US Key Responsibilities: # Upgrade service qualities and workforce efficiency for all Business Units in the United States, Canada & Europe. # Implement enhancement process &...Contract workLocal area
$99k - $252.45k
...SummaryThe OpportunityAs a Digital Assurance & Transparency - IT Audit Manager, you will play a pivotal role... ...regulations. As a Manager, you will lead teams and manage client accounts, focusing... ..., and inspire others to deliver quality. You are responsible for coaching,...Full timeH1b$175k - $210k
POSITION SUMMARY: The Quality Assurance Program Manager is responsible for providing operational support that enables the Quality Assurance organization... ...cross-functional projects, Rigel commercial partners, and GMP vendors to ensure timely completion of business-critical...Flexible hours
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