Senior Clinical Quality Lead: Cell Therapy GCP (Remote)
Aurion Biotech
- Remote job
A clinical-stage biotechnology firm is seeking a Senior Clinical Quality Associate to lead quality assurance activities in clinical research. This remote role requires strong knowledge of FDA regulations and GCP standards, with opportunities for growth in the innovative field of cell therapy. The ideal candidate will have a Bachelor’s degree and relevant QA experience, along with excellent communication skills and the ability to work independently. #J-18808-Ljbffr Aurion Biotech
- ...complex world of clinical trials to... ...life-changing therapies to patients... ...Join us as a Senior Project Manager... ...(Sr. PM) and lead the delivery... ...compliant with GCP and... ...delivering high-quality clinical programs... ...study execution. Cell & Gene... ...Opportunity for remote/hybrid working...Remote jobQualitySeniorWork at officeLocal areaWorldwideFlexible hours2 days per week
$148.3k - $241.9k
The Senior Clinical Study Lead (CSL) is expected to operate with high... ...Procedures (SOPs) and ICH/GCP. This role applies to... ...not eligible fully remote. This role is... ...related to study conduct, quality, timelines or budget... ...clinical trials within cell therapy and early phase...QualitySeniorLocal area$101.1k - $171.9k
(Senior) Clinical Team Manager Join Us as a Senior Clinical... ..., (RA, SLE, Gout), Cell & Gene Therapy and CAR-T in... ...the customer's time/quality/cost expectations, and... ...may assume regional lead or Clinical Study Manager... ...compliance with ICH GCP. In accordance to project...Remote workQualitySeniorContract workTemporary workLive inWork at officeLocal area$250.8k - $303.91k
...breakthroughs in cell therapy, this is work... ...Translational Medicine and Clinical Pharmacology is... ...diseases.The Senior Scientific... ...Bioanalysis, and leads internal teams and... ...scientific quality, adherence to GLP/GCP requirements, and... ...centers. Employees in remote-by-design or lab...Remote workQualitySeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work$170k - $195k
...patient-centered, clinical-stage... ...company developing cell therapies for patients suffering... ...to Accelerate, Lead with Clarity, Boldly... ...and Audits is a senior leader within the Quality Assurance... ...strategies. Location: Remote (West Coast... ...Quality Compliance, GCP & Risk...Remote workQualitySenior$113k - $155k
...to create and deliver life-changing therapies by accelerating research,... ...commercial-scale production, ensuring quality, efficiency and regulatory compliance... ...team at Thermo Fisher Scientific as a Senior Technical Sales Specialist, Cell Culture, BioProduction, where you'll...Remote workQualitySeniorTemporary workWork at officeRelocation package3 days per week$89.78k - $108.79k
...latest breakthroughs in cell therapy, this is work that... .... Position: Senior Specialist, Quality Assurance Investigations... ...teams. Lead meetings and represent... ...global participation in clinical trials, while our shared... ..., field-based and remote-by-design jobs. The...Remote workQualitySeniorHourly payFull timeTemporary workPart timeFor contractorsWork experience placementSummer workLive inLocal areaFlexible hoursShift work$115k - $135k
...and manufacturing of new drug therapies to get them faster to people... ...Development, Customer Focus, Quality and Excellence, Respect and Integrity... ...About The Role The Manager, Clinical Monitoring Services is... ...clinical research, ICH/GCP Guidelines and applicable regulations...Remote workQualitySeniorHourly payPermanent employmentContract workWork at office$236.25k - $341.25k
...Job title : Senior Clinical Lead, Early Clinical & Experimental... ...conjugates and immune cell engagers, for solid tumors... .... Ensure high quality documents, requiring strong... ...knowledge of GCP practices Able to acquire... ...experience with combination therapies and drugs targeting...QualitySeniorInterim role$152.15k - $184.37k
Position Summary The Senior Manager, Forecasting, WW Cell Therapy, independently develops, maintains... ...area. Generates high-quality, objective forecasts that... ...Independently lead the end-to-end forecasting... ...50% onsite. Field-based/remote-by-design: travel to visit...Remote workQualitySeniorFull timeTemporary workSummer workWorldwideFlexible hoursShift work$338k - $400k
...committed to developing therapies that make a... ...and execution of the clinical strategy to support... ...processes and abiding by GCP and ICH regulations... ...:* ## Ensures high quality clinical &... ...CDT) Leadership:* ## Leads the integration of... ...protein technology, and cell and gene therapy to...QualitySeniorOdd jobWorldwide$117.15k - $141.96k
Position Summary The Senior Scientist role is a technical... ...the Cellular Therapy product portfolio. Successful... ...methods in the Cell Therapy Quality organization. Implement... ...reports as appropriate. Lead project, CAPA and... ...centers. Employees in remote‑by‑design or lab‑based...Remote workQualitySeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workWork at officeImmediate startFlexible hours$131.75k - $159.65k
...breakthroughs in cell therapy, this is work that... ...commitment, we are leading the way to unlock... ...Therapy team. The Senior Manager, Cell... ...Manufacturing supports the clinical and commercial... ...with Quality, Supply Chain, MS&... ...centers. Employees in remote-by-design or lab-based...Remote workQualitySeniorHourly payFull timeTemporary workPart timeFor contractorsWork experience placementSummer workLive inWork at officeLocal areaMonday to FridayFlexible hoursShift work$123.37k - $149.49k
...breakthroughs in cell therapy, this is work that... ...commitment, we are leading the way to unlock... ...Therapy team. The Senior Manager, Cell... ...Chain, Manufacturing, Quality, MS&T, Planning,... ...centers. Employees in remote-by-design or lab-... ...participation in clinical trials, while our...Remote workQualitySeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaMonday to FridayFlexible hoursShift work$136.03k - $164.84k
## Senior Scientist, Cell Therapy TRC In Vivo PharmacologySeattle 400 Dexter... ..., and a desire to lead functional workstreams... ...author high‐quality scientific documents,... ...centers. Employees in remote-by-design or lab-based... ...global participation in clinical trials, while our shared...Remote workQualitySeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- ...Senior Director, GCP Quality Oversight at Bicara Therapeutics Position... ...GCP activities for clinical trials sponsored by... ...transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp... ...and neck squamous cell carcinoma and other...QualitySeniorContract workWork at officeLocal area3 days per week
$137.79k - $166.97k
...breakthroughs in cell therapy, this is work that... ...commitment, we are leading the way to unlock... ...Therapy team. The Senior Manager,... ...in class safety, quality, productivity and... ...products for both global clinical trials and commercial... .... Employees in remote-by-design or lab-based...Remote workQualitySeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- ...Manager, Biologics/Senior Regulatory... ...six FDA-approved therapies that treat PAH,... ...Biologics will lead regulatory... ...ensuring high-quality, timely regulatory... ..., nonclinical, clinical, quality, marketing... ...guidance, ICH, GCP, and/or GMP... ...xenotransplantation products, cell therapy, and...Remote workQualitySeniorLocal areaRelocation package1 day per week
$89.78k - $108.79k
...breakthroughs in cell therapy, this is work that... ...working-with-us. The Senior Specialist, QA... ...is responsible for quality oversight and approval... ...functional teams. Lead meetings and... ...centers. Employees in remote-by-design or lab-... ...participation in clinical trials, while our...Remote workQualitySeniorHourly payFull timeTemporary workPart timeFor contractorsWork experience placementSummer workLive inLocal areaFlexible hoursShift work$33.51 - $40.61 per hour
## DAY SHIFT: Senior Manufacturing Associate, Cell Therapy in Devens, MADevens - MA... ...commitment, we are leading the way to unlock the... ...with safety and quality in mind. We are searching... .... Employees in remote-by-design or lab-... ...global participation in clinical trials, while our...Remote workQualitySeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift workNight shiftRotating shiftDay shift$89k - $109k
...learn more. JOB TITLE: Senior Clinical Quality Associate LOCATION: Remote - candidates based in the... ...professionals at the forefront of cell therapy and cornea care... ...is to drive and lead Clinical Quality Assurance... ...interpretation of FDA, ICH-GCP, EMA, and other relevant...Remote workQualitySeniorFull timeDay shift$265k - $280k
...Senior Director, Safety And Pharmacovigilance We are a clinical-stage biotechnology company focused... ...killer (NK) cell-based therapies. Our mission is... ...community setting. Our lead product... ...to ensure high-quality safety reports are... ...Pharmacovigilance Practices, GCP, clinical trial...Remote workQualitySeniorFlexible hours$105.6k - $158.4k
...eGenesis is a clinical-stage biotechnology... ...the Company’s lead program and is... ...is seeking a Senior Clinical Research... ...(on-site and remote), and closeout... ...compliance with ICH-GCP, regulatory... ...safety and data quality and study compliance... ...(e.g., gene/cell therapy or transplant)...Remote workQualitySeniorInterim roleFlexible hoursShift work- ...Experience required. Cell therapy experience is strongly... ...Job Purpose: The Clinical Research Associate (CRA... ...guidelines such as ICH-GCP, and relevant local regulations... ...including Risk Based Quality Management (RbQM)... ...monitoring visits (remote and onsite), as well as...Remote workQualitySeniorLocal areaFlexible hoursShift work
- ...Senior Clinical Lead We are currently searching for experienced Clinical... ...contract while optimizing speed, quality and cost of delivery and in... ...e., Good Clinical Practice (GCP) and International... ...extended periods of time This is a remote / WFH opportunity...Remote workQualitySeniorContract workImmediate startWork from home
$245k - $260k
...Description The Senior Director of Clinical Operations will... ...on innovative T-cell engager therapies for immunology and... ...to ICH-GCP, FDA regulations... ...budget, and to quality standards. Prepare... ...track record of leading complex clinical... ...San Diego office. Remote permitted upon approval...Remote workQualitySeniorHourly payFull timeSummer workRelocation packageMonday to Friday$125k - $150k
...is an industry-leading biotech with locations... ...off-the-shelf therapies capable of... ...SUMMARY The Senior Clinical Trial Manager... ...within specified quality, time, and cost... ...We are open to remote work within the... ...SOPs, and ICH/GCP guidelines/regulations... ...benefits, and cell phone stipend....Remote workQualitySeniorWork at office2 days per week- ...Zenas is a clinical-stage global biopharmaceutical... ...therapies for patients... ..., Zenas' lead product candidate... ...across B cell lineage, to inhibit... ...of Global Quality Assurance, Clinical... ...Assurance, GCP/GLP is... ...hybrid, and/or remote vendor or clinical... ...outcomes to senior leadership...Remote workQuality
$247.4k - $305.6k
...is an industry-leading biotech with... ...off-the-shelf therapies capable of treating... ...The Senior Director, Clinical Data Management... ...the integrity, quality, and regulatory... ...CO but can be remote within the US.... ...requirements, including GCP, ICH, and... ...and/or cell or gene therapy...Remote workQualitySeniorFor contractorsInterim role2 days per week- (Senior) Clinical Statistical Programmer - SAS* Immatics... ...of the right T cell receptors with the... ...of Adoptive Cell Therapies and TCR Bispecifics... ...bingen, in Munich or remote (Germany). In this... ...and address data quality issues. Ensure... ...Clinical Practice (GCP), ICH guidelines,...Remote workQualitySeniorPermanent employmentFull timeSummer workImmediate startRelocation package
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