Global Lead, Clinical QA & Audits
Alkermes
Alkermes, Inc. is seeking an experienced CQA Auditor to join our team, supporting clinical programs by auditing sites, vendors, internal systems, and documents to ensure cGCP and GLP compliance. The role requires roughly 40% travel, onsite presence in Waltham, MA three days per week, and a degree in Nursing or Health Science with 10+ years of auditing. Strong communication skills and knowledge of GCP systems are essential. #J-18808-Ljbffr Alkermes
$150k - $200k
Medical Writing Lead, Global Clinical Operations, Orion Pharma Cambridge, United Kingdom and 3 more (Hybrid) Job Description Orion Pharma is a purpose-driven biopharmaceutical company committed to advancing innovative treatments for cancer patients worldwide. As we expand...SuggestedWorldwide- A leading biotech company based in Boston is looking for a Director, Clinical Operations Program Lead to oversee the execution of global oncology clinical studies. This role requires a minimum of 10 years in clinical research, with a background in oncology. You will manage...Suggested
- IQVIA is seeking experienced Clinical Data Management Leads to oversee end‑to‑end data management for global clinical trials. This is a remote/WFH position with all necessary equipment provided. You will lead cross‑functional teams, ensure quality and compliance, and act...SuggestedRemote jobWork from home
- Vertex Pharmaceuticals Inc (US) is looking for a Senior Director, Global Clinical Operations and Medical Writing Technology. This role involves leading a team focused on planning, design, and development for systems that support clinical operations. The candidate will be...Suggested
- AstraZeneca in Boston is seeking an Associate Director, Supply Chain to lead the design and execution of a global clinical supply chain for specialized therapies. This key role is responsible for overseeing the clinical supply chain process, ensuring seamless delivery...Suggested
$185k - $200k
Olema Oncology is seeking an Associate Director, Clinical Supply Chain to optimize drug supply for clinical programs. This role involves developing global strategies, overseeing inventories, and collaborating with clinical operations. Candidates should have over 8 years...- Treeline Biosciences in Watertown, MA is seeking a Head of Clinical Supply Chain to lead and develop the supply chain team. This role entails... ...overseeing external vendors and ensuring compliance with global regulations is essential for this position. #J-18808-Ljbffr...
- Takeda in Boston, MA is seeking an Associate Director, Quantitative Clinical Pharmacology Lead to drive strategic, scientific, and operational aspects of multiple drug development programs from first‑in‑human dosing through lifecycle management. You will integrate PK/PD...
- Iterative Health in Cambridge, MA, is seeking a Research Finance Manager, a senior leader overseeing clinical trial budgeting, contracting, and financial performance across our global network of sites. You will manage Budget Specialists and serve as the escalation point for...
- ...and services company powering the acceleration of clinical research to transform patient outcomes. We built a leading performance-driven network of 100+ sites across... ...financial performance across Iterative Health's global research network — overseeing a team of Budget...Contract workTemporary workFor contractorsFor subcontractorH1bWork at officeLocal areaWork visa2 days per week
$120 - $170 per hour
Associate Director, Clinical Program Quality Leader Base pay range: $... ...quality assurance oversight of the global clinical research programs in... ...a risk-based program audit strategy, ensuring communication... ...and mitigations are in place. Leads the clinical pre-approval inspection...Temporary workFor contractorsWork at officeImmediate startNight shift2 days per week- ...responsible for defining and executing the global strategy for tuning, optimizing, and... ...decisions. Translate regulatory findings, audit issues, and risk assessments into clear optimization... ...Monitoring Rulebook Optimization Lead the ongoing optimization of global TM rulebooks...
$154.4k - $242.55k
...Job Description About the Role: The Global Brand Lead, ITP (Associate Director) is responsible for driving global commercial initiatives... ...box Working across cultures – recognizing different business, clinical and legal practices; keeping compliance with Takeda’s values...Minimum wageFull timeTemporary workLocal areaRemote work$160k - $187k
Kura Oncology is seeking a Senior Manager, Clinical Quality Assurance, to spearhead quality oversight within clinical development programs... ...with various departments to ensure compliance, manage audits, and support inspections. Candidates should have extensive experience...Remote job$137k - $215.27k
A global biopharmaceutical company in Boston is seeking a Senior Manager, Biostatistics to provide strategic and hands-on statistical leadership for clinical development programs within the neuroscience portfolio. This role involves oversight of studies, innovative analytical...$154.4k - $242.55k
About the role Global Insights Lead, Nephrology (Associate Director) - Reporting to the Global Insights & Analytics Head; responsible for leading... ...actionable, decision-oriented insights that inform clinical development and early commercialization strategies. The role...Temporary workLocal area$228.2k - $358.6k
Scientific/Medical Lead, Global Medical Affairs Oncology Join to apply for the Scientific/Medical Lead, Global Medical Affairs Oncology role... ..., oncology PMO, MSL teams), as well as with commercial. clinical development, access & reimbursement, Takeda patient advocacy team...Minimum wageFull timeTemporary workLocal area- A clinical-stage oncology company is seeking a Senior Manager, Global Radiopharmaceutical Manufacturing, to oversee technology transfer and GMP manufacturing operations... ..., ensuring compliance with GMP regulations, and leading site selections. Ideal candidates should have a...Contract work
- ...Pharma, a Nordic pharmaceutical leader, seeks a senior leader in Clinical Data Management to guide oncology programs across trials. You... ...CDISC compliance, data quality, and submission readiness across global development. The role fosters cross‑functional collaboration...
$177k - $278.08k
Job Description The Global Product Strategy group is part of the Strategy and Portfolio Development... ...(PsA). The Director, Global Brand Lead (GBL) will: Support the development of... ...cultures - recognizing different business, clinical and legal practices; keeping compliance...Minimum wageFull timeTemporary workLocal area- Sanofi is looking for a Global Project Head to lead the clinical development strategy for solid tumor oncology compounds. This role involves managing cross-functional teams and collaborating with various stakeholders to ensure successful development and regulatory submissions...
- A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...Remote job
$232.5k - $310k
The Global Brand Lead, Migraine is responsible for defining and driving the global commercial strategy for Ipsen’s migraine franchise. The... ...segments, value proposition, and positioning strategy grounded in clinical differentiation and real-world value.Develop global launch...Temporary workFlexible hours$177k - $278.08k
Director, Global Brand Lead (GBL) The Global Product Strategy (SPD) team fuels Takeda's growth by commercializing a portfolio of therapies... ...engagement plan. Partner cross‑functionally with Medical and Clinical Science teams. Translate insights into brand strategy,...Full timeTemporary workLocal area$130k - $230k
Lead Clinical Data Management, ClinicalData Management, R&D, Orion Corporation Job Description... ...representative on regulatory inspections, audits, due diligence activities, and health... ...and SDTM, and their application within global development programs. Experience managing...Immediate start- SoTalent seeks a Senior Manager, Global Regulatory Affairs (CMC) to drive regulatory strategy and submissions for clinical development and post-approval. The role collaborates with development, QA, analytical, and manufacturing teams, ensuring alignment with global requirements...
$167k - $300.7k
...diseases, rare diseases, and oncology, we are seeking a Global Competitive Intelligence Lead-Oncology to lead Moderna’s commercial CI strategy across... ...geographies. Monitor and analyze competitor pipelines, clinical trial data, regulatory strategies, commercial activities...$130k - $230k
Statistical Programming Lead, Clinical Development Data Services, R&D, Orion Corporation You will join a growing oncology-focused Data Sciences... ..., and submission requirements. Experience supporting global regulatory submissions and interactions with health authorities...$206.25k - $297.92k
Job Title Global Lead, Medical Intelligence to Strategy Location Cambridge, MA; Morristown, NJ About the Job Sanofi is accelerating a modernization... ....” Build and lead the Data Strategy framework that integrates clinical evidence, real‑world data, field insights, and digital health...Shift work- Eacademy Sanofi is seeking a Global Atopic Dermatitis Medical Lead to drive the global medical strategy for Dupixent in Atopic Dermatitis. You will... ...operational execution, and collaboration across marketing and clinical teams. This pivotal role requires an advanced degree in...
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