Senior Quality Systems Lead - cGMP, Veeva & Compliance
Editas Medicine
Editas Medicine is seeking a Senior Specialist, Quality Systems Management, to advance our lead in vivo program and strengthen QA processes. You will support electronic document management, QMS, and training systems, while coordinating supplier qualification and audit activities. The role requires cGMP experience in biotech, cross-functional collaboration, and strong analytical and organizational skills. Join a team committed to improving patient outcomes through innovative gene-editing #J-18808-Ljbffr Editas Medicine
- Editas Medicine is seeking a Senior Specialist, Quality Systems Management in Cambridge, MA to lead and optimize quality... ...functions to strengthen compliance, manage electronic documents... ..., experience with cGMP, and hands-on work with Veeva Quality apps and compliance...QualitySenior
- ...is to advance our lead in vivo development... ...phase-appropriate quality systems and vendor... ...Your Impact: As the Senior Specialist, Quality... ...their effectiveness, compliance, and continuous improvement... ...system (Veeva QualityDocs), electronic... ...working within cGMP-regulated...QualitySeniorFlexible hours
$155k - $195k
...Summary of Position:The Senior Manager, Veeva Regulatory & Data... ...serves as the technology lead for enterprise... ...supporting Scholar Rock’s Quality, Clinical, Regulatory... ...service providers, systems integrators, consultants... ...based validation and compliance practices that...QualitySeniorFull time$151.2k - $226.8k
...processes, document control, training, and quality records support consistent compliance across functions and regions.Your... ...overdue items, training compliance)Lead QMS simplification/optimization,... ...g., ASQ, ISO Lead Auditor, Quality Systems)Training in electronic QMS...Quality$107.1k - $138.6k
...kidney, is the Company’s lead program and is... ...POSITION SUMMARY The Senior Quality Systems Specialist will be supporting... ...to established cGMP standards and regulatory... ...improvements to enhance compliance and improve method and... ...Experience in Qualio, Veeva and/or Benchling Experience...QualitySenior- Fagron US is seeking a Quality Assurance Senior Specialist to lead QA activities across Level 1-3 in a cGMP pharm manufacturing environment. You will ensure proper controls,... ...extensive QA experience, familiarity with quality systems, and strong documentation practices. Join a...QualitySenior
$93.6k - $154.5k
...environments where validated systems, reliable data, and regulatory compliance are critical to business... ...activities across quality, laboratory, manufacturing... ...sciences domain, including: Lead computer systems... ...MES and other ERP systems, Veeva Vaults (Quality, Clinical...QualitySeniorFull timeWork experience placementSummer holidayFlexible hours$228k - $342k
...DescriptionSenior Director, Quality Data, Digital Systems & ComplianceGxP Data Governance... ...position summary:The Senior Director, Quality Data, Digital Systems & Compliance, serves as a pivotal leader... ...oversight. The position promotes leading practices, supports organizational...QualitySeniorFull timeWork experience placementSummer workRemote workFlexible hours2 days per week$102.3k - $138.3k
Join Rapid7 as a Senior Business Systems Analyst - Finance & Accounting, where you will partner with... ...financial controls, SOX compliance, auditability, and data security requirements... ...operational usabilityThe skills and qualities you'll bring includeDemonstrated experience...QualitySeniorFull timeWork experience placementLocal area- Alnylam is seeking a Senior Manager, Medical Writing to collaborate with project teams on clinical document development in compliance with GCP and SOPs. The role oversees contract writers... ...clinical program and ensures timely, high-quality deliverables. The candidate will plan...QualitySeniorContract work
$212k - $333.19k
...lasting impact on patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory... ...all submission types are executed on time with high quality, including major submissions (NDA/BLA/MAA)For the project...QualitySeniorMinimum wageTemporary workLocal areaRemote workWorldwide- ...Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies for small molecule programs,... ..., and oversee responses to RFIs with minimal supervision, driving high-quality submissions and robust compliance. #J-18808-Ljbffr Relay TherapeuticsQualitySenior
$119.3k - $178.9k
...resolution, world-class regulatory compliance and advisory services, and... ...peers.Goodwin is seeking a Senior Business Systems Analyst / Product Owner to... ...a Big Four firm or another leading management or technology... ...adoption, user experience, quality, efficiency, and business...QualitySeniorFull time- A leading IT staffing company in Massachusetts is seeking a qualified... ...GMP operations and ensure compliance with regulations. The ideal candidate... ...with extensive experience in Quality and Compliance within the... ...benefits offered. #J-18808-Ljbffr Artech Information System LLCQualitySenior
- Fagron US is seeking a Quality Assurance Senior Specialist to lead cGMP QA activities across manufacturing, packaging, and product disposition for compounded products. You will ensure ALCOA-compliant documentation and robust change control across Level 1-3 QA tasks in...QualitySenior
- ...GMP Operational Quality Senior Manager The GMP Operational... ...quality assurance and compliance. This role coordinates... ...-functional quality systems Conducts GMP document... ...successfully leading event investigations,... ...g., QDocs, Trackwise, Veeva) 1 year contract with...QualitySeniorContract workShift work
- Fagron US is seeking a Quality Assurance Senior Specialist to oversee cGMP manufacturing QA activities, documentation, and product disposition for compounded... ...ALCOA standards while maintaining training and compliance. This role requires a college degree and 8-10 years...QualitySenior
- ...partnerships, CADM provides high-quality and efficient services to... ...Research Administration and Compliance Systems team to deliver software... ...their research projects. The Senior Business Analyst supports the... ...project team including technical lead, developers, and QA team...QualitySeniorWork at officeShift work
- ...YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins is... ...areas. Operates in compliance with regulations, company policies... ...regulatory product strategy and the Quality Dossier Program (QDP). Significant...QualitySeniorLocal area
- Werfen seeks a Senior Engineering Group Lead to own design controls and product reliability for Class II... ...output. This hands-on leader will set system integration strategies, develop plans... ...Mechanical, Electrical, Software, Quality, Regulatory, and PM teams while mentoring...QualitySenior
$130k - $170k
...bodies and daily lives.WHOOP is hiring a Senior Lead, DTC Commercial Planning & Strategy to... ...Analytics to build out the commercial operating system of the DTC business (planning,... ...assisted work aligns with the same high-quality standards as personal contributions.This...QualitySeniorFull timeWork at officeRelocation- ...tolerability, durability and quality of life. Are you ready... ...innovation? As the Senior Global Medical Affairs... ...investment decisions, lead pre-launch scientific efforts... ...and transforms health systems, leverages digital and... ....Regulatory Insight & Compliance: The Senior GMAL...QualitySeniorFull timeWorldwideRelocation package
- Philips is seeking a Supplier Quality Engineering Leader for Ultrasound to define and execute the supplier quality... ...strategy across the business. You will ensure regulatory compliance, drive supplier performance, and lead cross-functional collaboration with engineering and...QualitySenior
- Philips is seeking a Supplier Quality Engineering Leader for Ultrasound to drive supplier quality strategy, ensure regulatory compliance, and lead cross-functional collaboration across SQE, engineering, and procurement. The role requires 10+ years in quality or related...QualitySeniorWork at office
- ...an Associate Director, Medical Review Lead to join the team in Cambridge, MA. This... ...Case Safety Reports (ICSRs) to ensure compliance and quality of safety data. The successful candidate... ...significant impact in rare disease communities. #J-18808-Ljbffr Kinsley Power SystemsQualitySeniorRemote jobFlexible hours
$212k - $333.19k
...empower you to shine? Join us as a Senior Director, Global Program Lead- Neuroscience in our Cambridge, MA office... ...and strong sense of the time/quality balance. Provides matrix management,... ...budget (including proficient use of systems to improve reporting or access to data...QualitySeniorMinimum wageTemporary workWork at officeLocal areaRemote work- ...are seeking an experienced Senior Teleoperations Lead to oversee robotics operations... ...excellence, maintaining quality and safety standards, and serving... ...in robotics, autonomous systems, technical operations,... ...KPIs and productivity Ensure compliance with safety and quality...QualitySeniorShift work
- ...a better world. Join us.Job DescriptionAECOM is seeking a Senior Rail Systems Lead to join our World Class Transit/Rail Team in support of our... ...to recommend appropriate actions to ensure compliance with clients, local, state, and federal regulationsUnderstanding...SeniorWork at officeLocal areaWorldwideRelocationFlexible hours
- ...Boston area to maintain and calibrate plant and facility systems within regulated environments. You will operate the Building... ..., and drive reliability improvements while ensuring cGMP and GDP/GEP compliance. The role requires 9-15 years’ experience, high standards...Senior
$89k - $119k
...DoReporting to the Order-to-Cash Senior Product Manager, you'll own billing system operations and drive ongoing optimization... ..., to reduce operational and compliance risk.Partner with business... ...analysts to ensure consistency and quality.What You’ll Bring3+ years of hands...QualitySeniorWork at office
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