GMP Quality Operations Director (Clinical/GCP)
$156.6k - $234.8kScorpion Therapeutics
Scorpion Therapeutics in Boston is seeking a Quality Operations Leader who will oversee teams supporting GMP manufacturing and testing. The selected candidate will be responsible for ensuring compliance with quality standards and managing QA programs as well as audits. A Bachelor’s degree in a scientific field and significant experience in quality operations management are essential. The position also offers a competitive pay range of $156,600 - $234,800, along with potential bonuses and equity awards. #J-18808-Ljbffr Scorpion Therapeutics
$252k - $269k
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... ...division and touchpoints with GMP. Audit & Inspection Management Lead...SuggestedLocal areaWorldwide$118.4k - $177.6k
Job Summary The GMP Quality Operations Manager is an expert in quality assurance, compliance, and AI‑enabled quality operations. The role provides QA support for external manufacture of Cell & Genetic Therapeutic programs, driving activities related to product disposition...SuggestedSummer workFlexible hours$118.4k - $177.6k
Job Description The Quality Manager is an advanced technical resource in the principles and... ...improvement activities. Conducts GMP document review, including procedures, work... ...support and oversight of GMP manufacturing operation including batch disposition. Experience...SuggestedWork experience placement- Responsibilities Provide end-to-end GMP Quality oversight of CDMOs, contract laboratories,... ...packaging/labeling vendors supporting clinical and future commercial supply. Lead supplier... ...manufacturers. Partner with Technical Operations and CDMOs to support PPQ readiness and...SuggestedContract work
- Key Responsibilities Participate in cross-functional teams as a Quality technical resource, providing quality oversight and support to analytical... ...Quality Metrics to support process improvement. Conduct GMP document review (procedures, work instructions, specifications,...Suggested
- Vertex Pharmaceuticals is seeking an Associate Director, GMP Operational Quality in Boston to oversee team activities and ensure quality deliverables within department purview. The role requires comprehensive knowledge of quality assurance and compliance principles. You...
$253.33k - $286.67k
...seeking a seasoned, Sr. Director-level subject matter expert... ...the advancement of our clinical programs while upholding... ...to the Head of Clinical Operations, the Senior Director... ...reports. Compliance & Quality: Ensure adherence to SOPs and GCP/ICH guidelines; maintain...Full time$235k - $330k
...Who we are: Kymera is a clinical-stage biotechnology company pioneering... ...make an impact: The Senior Director, Clinical Operations is a leadership role responsible... ...project timelines, budget, and quality standards (including ICH GCP and local regulations)...Local area- Merck in Boston is seeking a Clinical Quality Operations Manager to ensure the highest quality in clinical trials through robust management strategies... ...years in clinical research and a profound understanding of GCP, this role requires strong project management and...Remote job
$210k - $230k
...Director, Clinical Operations As the Director, Clinical Operations, you will lead the clinical operations... ...executed studies, ensuring high-quality, efficient, and compliant execution across... ...studies are conducted in accordance with GCP, FDA regulations, ISO 14155, company...Full timeWork at officeRemote workRelocation$230k - $281k
...Senior Director, Clinical Operations Watertown, MA Patients with adenoid cystic carcinoma (ACC) have waited decades for a treatment... ...for timelines, budgets, enrollment, and quality in accordance with ICH GCP and applicable regulations. Build and drive comprehensive...$200k - $270k
...Clinical Operations Professional Ovid Therapeutics Inc. is a New York-based biopharmaceutical... ...the clinical studies on time, with high quality and within agreed budget Develop and... ...compliance with regulatory requirements, ICH-GCP requirements, and company SOPs...Work at officeLocal areaWorldwideFlexible hours$265k - $300k
A biopharmaceutical company is seeking an Executive Director, Clinical Quality Assurance to lead QA operations focused on GCP, GPvP, and GLP compliance. The ideal candidate will have extensive experience in regulatory practices, strong problem-solving skills, and the ability...Remote job$156.6k - $234.8k
...Duties and Responsibilities Lead a Quality Operations team supporting GMP manufacturing/testing, including disposition... ..., working cell banks, and clinical/commercial drug products. Manage QA... ...assigned clinical programs; provide GCP compliance interpretation, consultation...Work experience placementShift workDay shift$156.6k - $234.8k
## Associate Director, GMP Operational QualityApplylocations: Boston, MAtime type... ...Director, GMP Operational Quality is responsible for oversight... ..., working cell banks and clinical and commercial drug products... ...clinical programs providing GCP compliance interpretation,...Work experience placementSummer workRemote workFlexible hoursDay shift2 days per week$195k - $245k
...you? Frontier Medicines is seeking a Director, Clinical Operations Program Lead to drive the operational... ...clinical and business strategy into high-quality, on‑time study delivery across regions... ...with quality standards (ICH/GCP, Global Regulations, and company policies...Temporary workWork experience placement- Hemab Therapeutics is seeking a Senior Director of Clinical Operations — a high-impact leader who will drive... ..., within budget, and to the highest quality standards Drive rigorous planning... ...conducted in strict accordance with ICH/GCP requirements, applicable regulations,...Work at office
$160k - $275k
Who we are: Kymera is a clinical-stage biotechnology company pioneering... ...monitoring reports to ensure quality and resolution of site-... ...groups for review. Partner with Operational Excellence and assigned Site... ...including CFR, ICH GCP, HIPAA, GDPR, and the Protection...Contract work$265k - $300k
Executive Director, Clinical Quality Assurance Boston; San Francisco; Seattle About Jade Biosciences Jade... ...focused on Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GPvP... ...perform day‑to‑day clinical quality operations and compliance activities to support the...Work at officeRemote work- ...biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-... ...development, corporate, and commercial operations. About the Role: We are seeking a Director, Quality Assurance, GCP/GLP to join our team. We are building our...Contract workTemporary workWork at officeRemote work2 days per week
- AstraZeneca is seeking a Director Country Operations Management in Boston. The DCOM will lead a team responsible for study quality and deliverables, ensuring alignment with global study... ...role requires at least 7 years of clinical research experience, with proven leadership...Local area
- AstraZeneca GmbH is seeking a Director Country Operations Management in Boston, responsible for leading a local execution team in managing clinical trial deliverables according to regulatory and quality standards. The ideal candidate should have extensive experience in...Local area
$177k - $278.08k
...at the asset-level, a risk based quality management model that elevates clinical program performance, strengthens regulatory... ...Study Execution Teams, driving operational discipline, cross functional issue... ...and sustained adherence to global GCP and regulatory expectations...Minimum wageFull timeTemporary workLocal areaWorldwide$177k - $278.08k
...best of my knowledge. Job Description About the Role As Director, Clinical Program Quality & Excellence (CPQE), TAU, you will provide strategic quality... ...Execution Teams and ensuring compliance with global GCP and regulatory expectations. Through strong partnership with...Minimum wageFull timeTemporary workLocal areaWorldwide- ## Director Operations - Clinical Data ManagementApplylocations: Paris: Cambridge One Main: Londontime type... ...*** Define, implement, and oversee Quality Management (QM) within CDM. This includes... ...of international standards (ICH, GCP, CDISC ...) and regulations related to...Flexible hours
- Overview We are seeking a Manager, Clinical Supply Chain - Operations for our well known client in Cambridge... ..., including Clinical Operations, Quality Assurance, Regulatory Affairs, and... ...lifecycle. Foundational knowledge of GMP, GxP, GCP, and global regulatory requirements...Full timeWork at officeLocal area
$148k - $236.5k
Pioneering Medicines: Associate Director / Director, Clinical Operations Cambridge, MA USA What if... We could harness... ...management, regulatory affairs, and quality. Lead or contribute to the design... ...Maintain current knowledge of ICH‑GCP, FDA, EMA, and other applicable...For contractors$122.4k - $165.6k
## Manager, Clinical Supply Chain - OperationsUnited StatesApply... ...Manager - Clinical Supply Chain, Operations. In this position, you will... ...Clinical Operations, Quality Assurance, Regulatory Affairs... ...* Foundational knowledge of GMP / GxP / GCP and global regulatory requirements...Full timeTemporary workFlexible hours$294.25k
...ESSENTIAL JOB FUNCTIONS: The Executive Director, Clinical Business Operations serves as a strategic leader... ...focused on operational efficiency, quality, and execution excellence. * Benchmark... ...of Good Clinical Practice (GCP) and International Conference on Harmonization...Full timeSummer holidayWork at officeHome office$212k - $333.19k
...Description About the Role As the Senior Director, Head of Clinical Program Quality & Excellence (TAU), you will drive... ...Quality & Excellence team to embed operational excellence, patient safety, data... ...clinical programs Lead global GCP inspection strategy, including submission...Minimum wageFull timeTemporary workLocal areaWorldwide
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