Senior Clinical Study Quality Lead - GCP & Inspections
Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated is seeking a Clinical Study Quality Lead (SQL), Associate Director to oversee advanced QA of clinical trial operations and vendors across study phases. The role ensures trials meet GCP, protocol, and Vertex Quality System standards, with development of audit/quality plans and real-time inspection readiness. This position may evolve to include line management responsibilities and requires strong risk management, regulatory knowledge, and cross-functional #J-18808-Ljbffr Vertex Pharmaceuticals Incorporated
- Vertex Pharmaceuticals seeks a Senior Manager, Clinical Study Quality Lead to provide study-level GCP QA oversight for assigned trials. This on-site or hybrid role requires... ...with risk-based audit strategies, CAPA, and inspection readiness within sponsor, CRO, or regulated...QualitySenior
- Mix Talent is seeking a senior R&D Quality Assurance professional to assure GCP compliance for sponsored Clinical Development activities. The role... ...outsourcing governance, and inspection readiness across global studies. The candidate will lead QA initiatives, ensure regulatory...QualitySenior
- Monte Rosa Therapeutics seeks a Senior Director/Director Quality GCP to provide strategic oversight of phase-appropriate GCP and GCLP activities,... ...will author SOPs, develop risk-based GCP programs, and lead inspection readiness while coordinating with internal and...QualitySenior
- ...Inc is seeking an Associate Director, GCP/GLP/GVP QA to oversee GCP activities, ensure compliance and quality execution of clinical studies. You will develop and manage GCP quality... ...QMS, delivering GCP training, supporting inspections, and reviewing protocols, DSURs, IBs,...Quality
- Senior Director, GCP Quality Oversight at Bicara Therapeutics Position... ...GCP activities for clinical trials sponsored by... ...thorough reviews of study-related documentation... ...audits and external inspections to assess GCP... ...solid tumors. Bicara’s lead program, ficerafusp...QualitySeniorContract workWork at officeLocal area3 days per week
$185k - $235k
...Therapeutics is seeking a Director Quality GCP to provide strategic oversight of phase... ...activities supporting active pre-clinical and clinical programs through... ...feedback on regulatory submissions. Lead and participate in inspection readiness activities for regulatory...QualitySenior- Beeline Medicines is seeking a Senior Director, GCP Quality Assurance to provide strategic leadership... ...operational oversight for GCP QA across clinical development programs. You will... ...trials meet global GCP standards and inspection readiness. The role emphasizes senior...QualitySenior
- Senior Director / Director - GCP Quality Monte Rosa Therapeutics is seeking a Senior Director / Director... ...supporting active pre-clinical and clinical programs through... ...feedback on regulatory submissions. Lead and participate in inspection readiness activities for...QualitySenior
- Vertex Pharmaceuticals is seeking a Senior Manager, Clinical Study Quality Lead to provide study-level quality... ...assigned clinical trials, ensuring GCP compliance with global regulations,... ...audit strategy, CAPA support, and inspection readiness. On-site or hybrid work is...QualitySenior
- Senior Clinical Trial Manager - Contract - Remote, USJoin... ...Trial Manager to lead the execution of global clinical studies from startup... ...timelines, budgets, quality, vendor management... ...risk mitigation, and inspection readiness. You... ...compliance with protocols, GCP, and regulatory...QualitySeniorContract workRemote work
$130k - $190k
...establishing the leading, fully integrated... ...and experienced Clinical Data Management professional... ...clinical studies within our... ...Reporting to the Senior Director of Data... ...while ensuring high-quality, inspection-ready clinical data... ...CDISC standards, GCP/ICH requirements,...QualitySeniorFull timeInterim role$137.8k - $206.8k
Job DescriptionGeneral Summary:The Senior Manager, Clinical Study Quality Lead provides study-level quality oversight... ...with Good Clinical Practice (GCP), applicable global regulations, study... ...support, compliance trend analysis, and inspection readiness. The role partners...QualitySeniorFull timeSummer workRemote workFlexible hours2 days per week- ...Pharmaceuticals Inc. seeks an Associate Director, GCP/GLP/GVP QA to oversee GCP activities and ensure quality execution of clinical studies. You will drive GCP quality processes,... ...will manage audits, training, CAPAs, and inspections while supporting study documentation such...QualitySenior
$195k - $330k
Who we are:Kymera is a clinical-stage biotechnology company pioneering... ...on building an industry-leading pipeline of oral small molecule... ...including clinical protocols, study reports, consent forms;... ...programsDemonstrated experience delivering high quality clinical biomarker data to...QualitySenior$235k - $330k
...are:Kymera is a clinical-stage biotechnology... ...an industry-leading pipeline of oral... ...make an impact:The Senior Director,... ...timelines, budget, and quality standards (including ICH GCP and local... ...not limited to, study protocols, clinical... ...conductAccountable for inspection readiness and...QualitySeniorLocal area- Inspekt AI is seeking a Senior Photogrammetry Specialist to lead photogrammetry initiatives and advance 3D modeling for building inspections. The role focuses on refining processes, mentoring... ...image datasets, and deliver high-quality 3D outputs for web dashboards and inspection...QualitySenior
- ...Patient Safety Senior Medical Director... ...This role will lead Risk Management... ...lead, on clinical teams/programs,... ...development, audits and inspections.Key Duties and... ...-functional study and program teams... ...as Product Quality complaints, as... ...Solid knowledge of GCP, ICH and Global...QualitySeniorFull timeSummer workRemote workFlexible hours2 days per week
$160k - $240k
...OverviewAs the Associate Director, GCP/GLP/GVP QA, you will oversee... ..., ensure compliance and quality execution of clinical studies. You will assist in the development... ..., GCP/compliance updates.Lead or assist with GCP health authority inspections, assist clinical teams in...QualityContract workWork at officeImmediate startNight shift- Vertex Pharmaceuticals Incorporated seeks a Senior Manager, Clinical Study Quality Lead to provide study-level GCP QA oversight for assigned trials and partner with... ...on risk-based audit strategy, CAPA support, and inspection readiness in a sponsor-regulated environment. Required...Quality
$266k - $344k
Beeline Medicines is a clinical‑stage biotechnology company focused... ...and delivering category-leading precision therapies to... ...life fully. Job Summary The Senior Director, GCP Quality Assurance provides... ...maintaining a continuous state of inspection readiness. The Senior...QualitySeniorLocal areaNight shift2 days per week$80k - $150k
Senior Clinical Data Manager, Clinical Data Management... ...data management lead for oncology clinical... ...activities from study startup through... ...delivery of high-quality clinical data that... ...CDASH and SDTM), ICH-GCP requirements, SOPs... ...regulatory submissions, inspection readiness...QualitySenior$144.5k - $195.5k
Senior Manager, Clinical Data ManagementThe Senior Manager, Clinical... ...Management will lead and contribute to data... ...support of Alnylam studies across all stages of... ...best practices;Support GCP inspection readiness and... ...Clinical Research, Quality Assurance, Global Patient...QualitySeniorFull timeTemporary workLocal areaFlexible hours- Sarepta Therapeutics seeks a Sr. Manager, Corporate Quality - GCP to provide program-level QA oversight across clinical development and real‑world evidence, ensuring compliance with FDA, ICH, and international standards. As a core member of the Clinical Trial Team, you...QualitySenior
$110k - $135k
...ambition to become the leading dermatology... ...The OpportunityThe Senior Clinical Trial Manager (CTM... ...requirements and ICH/GCP guidelines and... ...timelines, budget, quality standards and operational... ...timelines for the study in partnership... ...for regulatory inspections at any timeServe as...QualitySeniorFull timeContract workTemporary workWork experience placementWork at officeLocal areaWorldwide$210.9k - $379.2k
...oncology drug developer lead Clinical Development for one or... ..., designing clinical studies, writing protocols,... ...audits and regulatory inspections related to clinical trial... ...of FDA, MHRA and ICH GCP guidelines to ensure the... ...to generate high-quality work, and sense of passion...QualitySeniorPermanent employmentFull timeWork at officeWork from home$71k - $96k
...Responsibilities Job Summary The Senior Clinical Studies Associate supports the... ...execution and adherence to quality standards. Essential... ...regulatory requirements, GCP guidelines and company... ...procedures. Support audit and inspection readiness activities by...QualitySeniorWork experience placementWork at officeLocal areaRemote work- ...evaluated in a Phase 3 study. Stoke’s initial... ...Purpose: The Sr. Clinical Trial Manager must... ...as a Global Study Lead in an outsourced... ...to the protocol, GCP and within timelines... ...compliance and quality is maintained. Oversees... ...File (TMF) meets inspection readiness...QualitySeniorInterim roleWork at officeRemote work1 day per week
- ...world's health. From clinical trials to... ...accordance with the Study Monitoring Plan (SMP... ...prevailing laws, GCP, and client standards... ...goals, timelines and quality Manage assigned... ...interactions/inspections Demonstrated knowledge... ..., drive / lead and work through others...QualitySeniorLocal areaRemote workWeekend work
- ...Senior Manager, Clinical Trials Job Location: Irvine, USA... ...trials, ensuring studies are delivered on... ...execute, and/or lead study-specific meetings... ...Data Management, Quality, Medical Affairs)... ...international GCP guidelines/... ...monitoring, close out and inspection readiness....QualitySeniorTemporary workLocal areaFlexible hours
- Tango Therapeutics seeks a Quality Assurance leader to own and continuously improve the QMS framework across GMP/GLP/GCP domains. You will drive document control, training, and data integrity while ensuring compliance across functions and regions. You will oversee change...QualitySenior
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