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
$137.8k - $206.8k
...DescriptionGeneral Summary:The Senior Manager, Clinical Study Quality Lead provides study-level... ...Good Clinical Practice (GCP), applicable global... ...not eligible for a fully remote work arrangement.Key Duties... ...products, or cell and gene therapy clinical trials.Experience...Remote workQualitySeniorFull timeSummer workFlexible hours2 days per week- ...breakthroughs and introduce new therapies. ProPharma partners... ...sciences, clinical research solutions, quality & compliance,... ...study. Functions as the lead site management resource... ...procedures (SOPs), GCP/ICH guidelines and... ...ProPharma supports remote working, we also recognise...Remote workQualitySeniorFull timeWork at office
$140k
...next-generation therapies that bolster... ...immunotherapy and cell therapy... ...Summary The Senior GCP Auditor ensures... ...guidelines, and clinical study protocols... ...compliance to the GCP Quality Management... ...applicable. Lead development and... ...works onsite or remote as noted in the...Remote workQualitySeniorTemporary workFlexible hoursWeekend workAfternoon shift$160k - $217k
Outpace Bio is seeking a Senior Manager / Associate Director of Clinical Operations based in Seattle, WA. This role entails overseeing all operational aspects of cell-therapy clinical trials, ensuring compliance, quality, and efficiency. Candidates must have a Bachelor’...Remote jobQualitySeniorFlexible hours$75k - $115k
...mission is to provide top-quality services that help... ...treatment programs that lead to success. 39510... ...POSITION OVERVIEW: The Senior Clinical Supervisor is an advanced... ...Supervisory hours and therapy hours Accurately... ...community, or via telehealth, remote or typical office...Remote workQualitySeniorWork at office- ...allogeneic stem cell transplant has... ...prove fatal or lead to serious conditions... ...cell therapies with the goal of... ...advancing our clinical pipeline and supporting... ...highly skilled Senior Process... ...MFG), MSAT, CMC, Quality Assurance, and... ...permitted by law. For remote-based positions...Remote workQualitySeniorFull timeLocal area
- 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
$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... ...design, field-based and remote‑by‑design. The model assigned...Remote workQualitySeniorHourly payFull timeSummer workLocal areaImmediate startFlexible hours$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
...breakthroughs in cell therapy, this is work that... ...commitment, we are leading the way to unlock... ...Manufacturing is seeking a Senior Manufacturing... ...with safety and quality in mind. We are... ...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 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
- ...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-...Remote workQualitySeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaWorldwideFlexible hoursShift work
$158k - $185k
...Senior Clinical Trial Manager Remote Summit Therapeutics Inc. is... ...focused on improving quality of life,... ...including: Non-small Cell Lung Cancer (... ...investigational therapy not presently approved... ..., while leading and driving deliverables... ...ICH guidelines/GCP with a deep...Remote workQualitySenior- ...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
$125k - $150k
...Senior Clinical Trial Manager Umoja Biopharma... ...is an industry-leading biotech with... ...off-the-shelf therapies capable of treating... ...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$192k - $206k
...Overview Senior Clinical Trial Manager... ...Operations Remote, US Opportunity... ...operational strategy and leading planning... ...timelines, budget, quality, and regulatory... ...standards (ICH/GCP, internal SOPs)... ...class targeted therapy for patients... ...dendritic cell neoplasm (BPDCN...Remote workQualitySeniorContract workWork at office- ...Therapeutics in Cambridge, MA is seeking a senior program leader to manage end-to-end clinical supply chain readiness and execution for time-critical cell therapy logistics—from manufacturing slot... ...with manufacturing slots, and lead cross-functional teams to meet deadlines...Senior
- ...commercialization of therapies that degrade... ...and non-small cell lung cancers;... ...Summary The Senior Director, Clinical Scientist is... ...medical data; lead or provide content... ...Haven, CT, or remote from a... ...functional measures, quality-of-life... ...knowledge of ICH-GCP, the drug-development...Remote workQualitySeniorWork at office
$144.06k - $205.8k
...transformative therapies in disease areas... ...related clinical trial staff across... ...timelines and quality standards, including... ...Operations Leads and/or Clinical... ...knowledge of ICH/ GCP guidelines and... ...Northbrook, IL. Remote work from anywhere... ...with senior leadership and...Remote workQualityWork at officeLocal areaWork from homeWorldwide- Boston Scientific in Marlborough, MA, seeks a Principal Clinical Quality Assurance Specialist to lead the internal clinical QA program for assigned areas,... ...-functional teams to ensure investigations comply with GCP, ISO 14155, ISO 13485 and company policies. You will serve...QualitySenior
$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- ATCC Biotechnology is seeking a Senior Manager, Product - Cell Models & Reagents to lead the Cell Systems portfolio, including... ...media, serum, and reagents. This remote role will own strategy, lifecycle... ...Operations, Sales, Marketing, Quality, and R&D; leading a team of product...Remote jobQualitySenior
- ...Job Description Job Description As Clinical Lead at Lifetime Recovery, you will support the... ...to the clinical team to ensure high-quality, ethical, and consistent care delivery.... ...providing individual, group, and family therapy as needed. ● Participate and assist in...QualitySenior
$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$93.1k - $232.8k
Senior Clinical Project Manager - Global Study LeadershipAt... ...of life-changing therapies.This is an opportunity to lead large-scale, multi-... ..., Respiratory, Cell & Gene Therapy, Infectious... ...-out, ensuring quality, timeline, budget,... ...with ICH-GCP, regulatory requirements...QualitySeniorFull timePart timeImmediate startWorldwideFlexible hours- ...Overview: The Senior Manager, Biostatistics provides... ...for complex clinical studies in cell therapy oncology programs. Responsible... ...: Serve as lead statistician for one... ...deliver timely, high-quality statistical outputs.... ...Professional office or remote work environment;...Remote workQualitySeniorWork at office
$106.1k - $295.5k
Job OverviewAssociate Clinical Lead Directors are an integral part of clinical trial delivery,... ...Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (... ...developing clinical strategies.• Ensure clinical quality delivery by identifying quality...QualityFull timeContract workPart timeWork at officeLocal areaImmediate startWorldwide$143.23k - $185.35k
...breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we’re not... ...(e.g., SoX, GxP, GAMP) and internal quality standards. Collaborate with business... ...collaborating with virtual or remote teams Willingness to travel People Leader...Remote workQualitySeniorLocal area- RoslinCT US is seeking a Quality Control Technical Services Senior Analyst - Contractor to support optimization, qualification, transfer, and verification of analytical methods for cGMP cell therapy production. The role involves writing SOPs, test methods, and data capture...QualitySeniorFor contractorsFlexible hours
$143.29k - $266.11k
...PositionThis role is a vital part of our Cell Therapy Process Development team within Pharma... ...optimization. As a member of this team, you will lead cutting-edge efforts to develop and... ...Development, Research, Manufacturing, Quality) and external collaborators to align...QualitySeniorFull timeLocal areaRelocation package
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