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
$78k - $156k
...healthcare, with leading businesses and products... ...recruiting for a Senior Clinical Site Lead to join... ...Cardiovascular therapies (Vascular, Cardiac... ..., and ICH-GCP and clinical research... ...and required data quality. Understand and... ...States of America : Remote ADDITIONAL LOCATIONS...Remote workQualitySeniorFull timeContract workLocal areaShift work- Aurion Biotech Inc. is seeking a Senior Quality Associate for a fully remote role based in the United States (WA preferred). The successful candidate... ...collaborate with CDMOs and CTLs to ensure compliant cell-therapy products. Requirements include a Bachelor’s in biology...Remote jobQualitySenior
$140k - $269k
...innovative Associate Director Lead or Senior Associate Director Lead to join our Clinical Pharmacology team!... ...performs high quality pharmacometric (PMx) analyses... ...oligonucleotides, gene therapy, etc. Ensures timely... ...Both Levels: Remote: this position is considered...Remote workQualitySeniorFull timeLocal areaRelocation package- ...Colombia, Chile and Peru and seeks an experienced Senior/Principal Clinical Data Manager to build the LATAM Data Management... ...lock, develop CRF specs, and manage data quality for trials that accelerate innovative therapies to patients. The role requires 8+ years (Sr.) or...Remote jobQualitySenior
$217k - $325.49k
...AstraZeneca is seeking a Senior Director of... ...for the end-to-end Cell Therapy manufacturing... ...objectives across clinical and commercial stages... ...team, ensuring high-quality and timely program... ...content. Lead MSAT preparedness... ...— particularly in remote and matrixed environments...Remote workQualitySeniorWork at officeFlexible hours3 days per week$176.05k - $213.33k
...those who do it. The Cell Therapy Thematic Research... ...research, clinical development, and patient... ...Responsibilities Lead the Molecular Assays... ...performance, data quality, technical... ..., field‑based and remote‑by‑design. The model... ...Information R1607769 : Senior Principal Scientist...Remote workQualitySeniorHourly payFull timeSummer workLive inFlexible hours$229.38k - $277.96k
...breakthroughs in cell therapy, this is work that... ...Position Summary The Senior Director,... ...cell therapy into clinical practice across these... ...Responsibilities Lead development and... ...consistent, high-quality execution across regions... .... Employees in remote-by-design or lab-based...Remote workQualitySeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaWorldwideFlexible hoursShift work- Fully Remote • New Providence, NJ • Clinical Science & Operations... ...DescriptionTransforming Cancer Therapy TogetherAt... ...LinkedIn.The Senior Clinical... ..., etc.)Lead ongoing... ...lifecycle planning.Quality, Compliance &... ...with ICH-GCP, FDA/EMA regulations... ...aggressive B-cell lymphomas (...Remote workQualitySeniorFor contractorsWorldwideFlexible hours
$89.78k - $108.79k
...Position Summary The Quality Assurance Shop Floor team... ...of Shop Floor QA, the Senior Specialist shall serve... ...techniques. Coordinate and lead area walkthroughs to... ...biopharmaceuticals or cell therapy manufacturing is preferred... ..., field-based and remote-by-design. The model assigned...Remote workQualitySeniorHourly payFull timeTemporary workWork experience placementSummer workLocal areaMonday to FridayFlexible hoursDay shift$171.2k - $256.8k
...discover and develop therapies that take aim at critical... ...ability of cancer cells to evade immune cell... ...SummaryThe Director, GCP & GLP QA, reporting to... ...Executive Director, Quality, is responsible for leading quality assurance oversight across clinical and nonclinical programs...QualitySeniorContract work$33.51 - $40.61 per hour
...reimagining the future of cell therapy. With our bold... ...term commitment, we are leading the way to unlock the... ...Manufacturing is seeking a Senior Manufacturing... ...efficiently with safety and quality in mind. We are searching... ..., field-based and remote-by-design. The model assigned...Remote workQualitySeniorHourly payFull timeSummer workLive inLocal areaFlexible hoursShift workNight shiftRotating shift- ...world's health. From clinical trials to... ...the development of a therapy that ultimately will... ...experience required. Cell therapy experience... ...guidelines such as ICH-GCP, and relevant local... ...including Risk Based Quality Management (RbQM)... ...monitoring visits (remote and onsite), as well...Remote workQualitySeniorLocal areaFlexible hoursShift work
$246k - $290k
...focused on improving quality of life,... ...through Summit's clinical studies in the field... ...: Non-small Cell Lung Cancer (... ...investigational therapy not presently approved... ...data. The Senior Director will develop... ...~ Lead the development... ...of ICH, FDA and GCP regulations and...Remote workQualitySeniorInterim role$150k - $165k
...groundbreaking therapies. Our mission is... ...commitment to quality, and a collaborative... ...possible.The Senior Program Manager... ...for leading Aldevron's most... ...and late-phase clinical programs progressing... ...will be fully remote.In this role, you... ...and its use in cell and gene therapy...Remote workQualitySeniorFull timeWork from homeFlexible hoursNight shift- ...Pharmaceuticals Holdings, Inc. in Norwood, MA seeks a Clinical Trial Manager to lead day-to-day trial execution across phases... ...-functional collaboration to ensure quality and on-time delivery. Applicants should have advanced knowledge of GCP/ICH guidelines and experience in phase 1...Remote jobQualitySenior
- Ascendis Pharma is seeking a Sr. Clinical Trial Manager to lead global and regional trials from Palo Alto, CA or remotely. The role collaborates... ...completion on time and with high quality. The Sr CTM will manage... ...relations, ensuring regulatory and GCP compliance while supporting...Remote jobQualitySenior
- ...focus: advancing therapies for patients... ...Overview As a Clinical Operations Lead , you will provide... ...plan, ICH-GCP guidelines and... ...visit reports for quality, compliance and... ...employees Monthly Cell Phone and Remote Work Allowance... ...accordance with your seniority; social...Remote workQualityPermanent employmentFull timeSummer workWork at officeLocal areaFlexible hours
- ...Title: Senior Director, Global Clinical Development Lead – Rare Disease (Nephrology)” Company:... ...partners to deliver high-quality studies on time and within... ...interpretation, in line with ICH-GCP, applicable regulations... .... Location: Remote in Europe or East Coast US...Remote workQualitySeniorFull time
$95k - $120k
...science and robust clinical pipeline form... ...spanning TCR T-cell therapies and TCR... ...and proactive Senior Clinical Trial... ...highest standards of quality. Reports to:... ...Director, Team Lead Site Operations... ...Location: US,Fully Remote Salary... ...industry with ICH-GCP knowledge, or...Remote workQualitySeniorFull timeTemporary workWork experience placementImmediate start$157k - $196.3k
...rare diseases, cell & gene therapies and CNS. With... ...Overview The Senior Manager,... ...partners. This role leads and supports... ...with Clinical Development, Regulatory... ..., and quality across individual... ...requirements and GCP/GVP/ICH safety... ...Primarily remote role with periodic...Remote workQualitySeniorFull timeInterim roleWork at officeFlexible hours$165k - $180k
...edge science and robust clinical pipeline form the... ...modalities, spanning TCR T-cell therapies and TCR bispecifics.... ..., Clinical Operations Lead to support our Clinical... ...: US, Fully Remote Salary Range: $165,000... ...trial partners to ensure quality, compliance, timelines...Remote workQualityFull timeTemporary workImmediate start$192k - $206k
Overview Senior Clinical Trial Manager Global... ...Clinical Operations Remote, US... ...operational strategy and leading planning... ...timelines, budget, quality, and regulatory... ...standards (ICH/GCP, internal SOPs)... ...class targeted therapy for patients... ...plasmacytoid dendritic cell neoplasm (BPDCN...Remote workQualitySeniorContract workWork at office$160.6k - $240.8k
...DescriptionGeneral Summary:The Clinical Study Quality Lead (SQL), Associate... ...in accordance with GCP requirements,... ...Leadership Team and senior stakeholders in GCP... ...clinical studies or Cell and Gene Therapy is advantageous.Professional... ...as: 1. Hybrid: work remotely up to two days per...Remote workQualityFull timeWork experience placementSummer workWork at officeFlexible hours2 days per week- ...The Senior Contracts Attorney provides commercial... ...agreements, quality technical... ...Information: Hybrid or remote (with internal... ...of CRISPR cell and gene therapies through cutting-edge... ...discovery through clinical trials. From streamlined... ...our industry-leading experts, Synthego...Remote workQualitySeniorContract work
$200k - $290k
...Director/Senior Director, Clinical Quality San Francisco, CA or Remote or Hybrid About us: Braveheart... ...focused on developing therapies for patients with hypertrophic... ...diseases. Our lead product candidate, BHB-... ...compliance effectiveness GCP Quality Oversight...Remote workQualitySeniorFlexible hours- Bristol Myers Squibb in Summit, NJ is seeking a Senior Specialist, QA Investigations to provide quality oversight for deviation investigations and related records at the Summit Cell Therapy Facility. You will review investigations, CAPAs, and effectiveness checks, ensure...QualitySenior
- ...Medical is hiring a Remote, Senior Clinical Research Project / Trial... ...studies and leading multidisciplinary teams... ...management, regulatory and quality functions... ...Experience with gene therapy or rare disease studies... ...subjects protections and GCP training (e.g., CITI...Remote workQualitySeniorFull timeContract work
- Danta Technologies is seeking a Senior GCP Data Engineer in Secaucus, NJ (Remote). You will design and maintain scalable data pipelines on GCP, focusing on... ...build reusable data models, optimize costs, and ensure data quality and security #J-18808-Ljbffr Danta TechnologiesRemote jobQualitySenior
- ...applicable through on-site and remote monitoring activities.... ...deficiencies and issues to clinical management expeditiously and... ...protocol and regulatory and ICH GCP obligations, making recommendations... ...Monitor. Experience in Cell and Gene Therapy (CGT) is mandatory for this...Remote workSeniorPermanent employmentWork at officeFlexible hours
$145k - $175k
...generation, life-changing therapies. Surrounded by a... ...possible.The Senior Manager, Clinical Programs is a... ...Diagnostics. You will lead a team of... ...and will be fully remote. In this role, you... ...and ensuring high-quality study execution standards... ...with ICH-GCP guidelines, regulatory...Remote workQualitySeniorFull timeWork from homeFlexible hours
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