GCP Quality Lead - Clinical Trials Oversight
Monte Rosa Therapeutics
Monte Rosa Therapeutics is seeking a GCP Quality expert in Boston, Massachusetts, to oversee quality for Phase I-III clinical trials. Your primary responsibilities include managing GCP compliance, conducting audits, and providing training to teams. The ideal candidate has a BS degree in a life science and 8+ years in the pharmaceutical industry. Knowledge of global regulations is essential. Join us to advance quality in our active clinical programs and support regulatory inspections. #J-18808-Ljbffr Monte Rosa Therapeutics
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A clinical-stage biotechnology company is seeking an... ...Director of Clinical Quality Assurance to oversee quality... ...for clinical trials. This remote role requires expertise in GCP, GPvP, and GLP, ensuring... ...include providing QA oversight, leading risk-based audit strategies...QualityRemote work- ...dedicated to drug discovery, clinical development, and... ...3 azetukalner clinical trials underway in major depressive... ...are seeking a Director, Quality Assurance, GCP/GLP to join our team. We... ...week. Responsibilities: Lead and manage quality oversight of the Company’s GLP programs...QualityContract workTemporary workWork at officeRemote work2 days per week
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...Clinical Quality Assurance Senior Leader provides strategic leadership and operational oversight of Alkermes GLP/GCP/GVP quality programs to ensure compliance across global clinical trials. This leader ensures the organization... ...objectives. Develop and lead Risk Management...QualityLocal areaWorldwide$132.5k - $338.3k
We are seeking an experienced GCP Data Architecture Lead to drive large-scale cloud data transformation initiatives and architect modern, enterprise... ...frameworks, and governance standards to improve data quality, accessibility, and compliance. Implement and manage modern...QualityWork experience placementLive inWork at officeLocal area- Vertex Pharmaceuticals is looking for a Senior Manager, Clinical Study Quality Lead, to provide quality oversight for clinical trials. The role encompasses GCP quality assurance, risk-based audit strategies, and compliance management. This position offers a hybrid work...Quality
$160k - $187k
...continue to build a leading biotech... ...Executive Director of Quality Assurance, the Senior Manager, Clinical Quality Assurance (... ...quality and compliance oversight utilizing proactive... ...clinical development, trial operations, pharmacovigilance... ...teams to provide GCP compliance guidance...QualitySummer holidayWork at officeHome office- ...Therapeutics is a clinical-stage biopharmaceutical... ...a Clinical Trial Manager to join our... ...is responsible for leading the execution of clinical... ...and ICH/GCP guidelines. Supports... ...RFP’s and vendor oversight plans. Responsible... ...delivery to both quality and agreed timelines...Quality3 days per week
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Executive Director, Clinical Quality Assurance Boston; San Francisco... ...diseases. Jade’s lead candidate, JADE101,... ...in a Phase 1 clinical trial for the treatment of immunoglobulin... ...Clinical Practice (GCP), Good... ...hands on clinical QA oversight and review of protocols...QualityWork at officeRemote work$140k - $160k
...partnerships with leading global biopharmaceutical... ...for global clinical development. Our unique... ...independent quality control (QC) assessments... ...clinical trials in accordance with study protocols, GCP, and company procedures... ...targeted, risk‑based QC oversight through on‑site QC...QualityWork at officeRemote workWorldwideRelocation package$159k - $195k
...Do The Associate Director, Clinical Oversight (ADCO) provides strategic leadership... ...framework that ensures high-quality trial execution, regulatory... ...Responsibilities Define and lead the Clinical Monitoring... ...and Good Clinical Practice (GCP) Develops key performance indicators...QualityFull timeWork at officeLocal areaFlexible hours3 days per week$161.5k - $202k
...of the high cost and time of clinical trials. Recognizing that this... ...The Associate Director, GMP Quality Assurance is responsible for... ...decision‑making Ability to lead investigations and write clear... ...documents Experience with CMO oversight or virtual manufacturing models...QualityWork at officeLocal areaRelocation3 days per week$192.6k - $260.6k
Overview Director, Clinical Quality Risk & Portfolio Oversight leads enterprise-wide quality intelligence, portfolio risk surveillance, and centralized quality... ...associated with computerized systems supporting GCP study related activities. Develop quality oversight framework...QualityLocal areaRemote workShift work$160.6k - $240.8k
General Summary The Clinical Study Quality Lead (SQL), Associate Director is responsible for advanced quality assurance oversight of clinical trial operations and applicable vendors, across a range... ...are conducted in accordance with GCP requirements, applicable protocols...QualityWork experience placementSummer workWork at office- ...on delivering only the best quality talent, the first time and every... ...Information Technology (IT), Clinical Research, Rehabilitation... ...review and approve clinical trial adverse event coding as needed... ...communication with internal DM staff and oversight of vendors performing coding...Quality
$143k - $175k
...You’ll Do The Senior Clinical Trial Manager (Sr. CTM) will... ...planning, execution, and oversight of one or more... ...as a key operational lead, the Sr. CTM will be responsible... ...with regulatory and quality standards. This role... ...continuous compliance with GCP, ICH, and global...QualityFull timeWork experience placementWork at officeLocal areaFlexible hours3 days per week
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