Senior Quality Systems Lead - CAPA & Compliance
ABCorp
ABCorp is seeking a Senior Quality Systems Specialist to enhance quality practices during a transformative period. This high-impact role focuses on the Quality Management System and aims to improve execution and process consistency. The ideal candidate will have over 5 years of relevant experience, strong organizational skills, and a history of effective collaboration across teams. This position offers the opportunity to influence quality standards and drive improvements in a leading secure manufacturing environment. #J-18808-Ljbffr ABCorp
- American Banknote Corp. is seeking a Senior Quality Systems Specialist to enhance quality practices during operational change. This critical... ...assurance and a solid understanding of quality systems and compliance. You will support the Quality Management System, coordinate...Quality
$151.2k - $226.8k
...document control, training, and quality records support consistent compliance across functions and... ...items, training compliance)Lead QMS simplification/optimization, including CAPA prevention initiatives based... ...ISO Lead Auditor, Quality Systems)Training in electronic QMS...Quality$142k - $213k
...personalized, predictive, and precise. Description The Quality Systems and Compliance Lead drives quality excellence at Verily by owning one or more... ...and implement effective corrective and preventive actions (CAPA). Staffs and develops their QA team with the skills and...QualityFull time- ...Senior Quality Systems SpecialistFrom our nation's earliest days, ABCorp has been a trusted force... ...longer. We maintain global reach and compliance with eight locations around the world,... ...reporting for recurring quality issues, CAPA aging, audit findings, scrap/rework themes...QualitySeniorWorldwide
- ...Cambridge-based biotech company, is hiring a Senior Quality Systems Specialist to bolster QA across GMP... ...processes, manage deviations and CAPAs, oversee documentation and training programs... ...to quality metrics and regulatory compliance in a fast-paced environment. #J-18808...QualitySenior
$151.2k - $226.8k
...document control, training, and quality records support consistent compliance across functions and... ...items, training compliance) Lead QMS simplification/optimization, including CAPA prevention initiatives based... ...ISO Lead Auditor, Quality Systems) Training in electronic QMS...QualityContract workFor contractorsFor subcontractorWork at officeVisa sponsorshipFlexible hours- Tango Therapeutics seeks a Quality Assurance leader to own and continuously improve the QMS framework... ...training, and data integrity while ensuring compliance across functions and regions. You will oversee change control, CAPA prevention, and audit readiness, partnering...QualitySenior
- Vertex Pharmaceuticals Incorporated is seeking a Quality Systems Associate Director to design and ensure execution of quality systems across... ...improvements. The role reports to the Director of Quality and leads APQR/QPQA, Data Integrity, and risk management initiatives, with...QualitySenior
- Harvard University is seeking a Lead Analyst for HR Systems to serve as a functional lead across university-wide HR applications including LMS and... ...HR, finance, and faculty affairs, and delivering high-quality systems for complex HR operations. #J-18808-Ljbffr Conditions...QualitySenior
- Klaviyo is seeking a Senior Systems Engineer to own our enterprise GTM systems end-to-end, including Salesforce and its integrations. You’ll drive platform health, code quality, and reliable data flows across the GTM stack, partnering with product, architecture, and partner...QualitySenior
$251.77k - $307.72k
...We are seeking an experienced QMS and Digital Compliance Senior Director to lead transformational change within our quality compliance organization. This leadership role... ...partnerships, maturing the quality management system and digital compliance footprint to support commercialization...QualitySeniorFull time- HR Recruiting Service is seeking a Quality Professional in Boston, Massachusetts, to maintain quality systems and ensure compliance with established standards. The ideal candidate will have extensive experience in ISO standards, regulatory audits, and supervisory roles...Quality
- Kymera Therapeutics is seeking a Quality Systems professional to manage the operational infrastructure of the QMS, including document control, training program management, and compliance monitoring. This role ensures GxP documents and personnel training records meet regulatory...Quality
- • Support the Head of QA with oversight of Verastem Quality Systems and QA activities in accordance with GXP requirements • Develop and... ...to support commercial and clinical stage operations • Drive compliance with current regulations and oversight of external GMP Quality...QualitySeniorFlexible hours
- Candel Therapeutics, Inc. in Needham is seeking a senior quality systems professional in a hybrid role with 3 days on-site and 2 days remote. You will own vendor oversight, CSV, and GxP system effectiveness, reporting to the SVP of Quality. The role requires 10+ years...QualitySeniorRemote work
- Vertex Pharmaceuticals in Boston seeks a Senior Director, Quality Systems to lead quality management and systems across global operations. The ideal candidate will have a strong background in regulatory compliance, operational excellence, and quality oversight. This role...QualitySenior
$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- Lilly is seeking an Associate Director-Medical Writer to lead and drive the development of high-quality regulatory and scientific documents for submissions... ..., and legal teams to ensure accuracy and regulatory compliance. The role requires 8+ years in medical writing within...QualitySenior
- Beeline Medicines seeks a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory science for biologics assets, including monoclonal antibodies,... ...collaborate with Process Development, Analytical Sciences, Quality, and external CMOs to align with FDA/EMA...QualitySenior
- Agomab Therapeutics seeks a Senior Director of Medical Writing to anchor our hybrid medical... ..., owning narrative strategy and document quality. You will balance AI-enabled tools with... ...ensure audit-ready submissions. You will lead CRO relationships, set standards, templates...QualitySeniorRemote job
- Synterex, Inc. is seeking a senior medical writer to lead planning and preparation of high-quality regulatory documents within our medical writing team. You will partner... ...contributors, manage timelines, ensure compliance with ICH US requirements, and contribute to templates...QualitySeniorRemote job
- 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
- ...experienced mathematical modellers, where one will use Quantitative Systems Pharmacology, mathematical modelling, and computational skills... ...(such as machine learning) to enhance the robustness and quality of decision-making from exploratory research, clinical development...QualitySeniorLocal area
- ...Cross Blue Shield of Massachusetts is seeking a Finance Systems Senior Solution Architect to lead the architectural strategy for core financial... ...will develop a multi-year technology roadmap and ensure compliance with security standards while leveraging emerging technologies...Senior
$107.1k - $138.6k
...Senior Quality Systems Specialist eGenesis is a clinical-stage biotechnology... ...porcine kidney, is the Company's lead program and is currently... ...and manage deviations and CAPAs ensuring timely closure across... ...improvements to enhance compliance and improve method and product...QualitySenior$115k - $150k
Title: Senior Business Systems Analyst, Corporate SystemsDepartment: Information... ...is one of the world's leading private investment firms. We... ...partner broadly across Legal, Compliance, Tax and other firm... ...prioritize assignments to deliver quality work in a timely manner.Strong...QualitySeniorFull time- ...and YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Therapeutic Neurotoxins is... ...-functional areas. Operates in compliance with regulations, company policies... ...product strategy and the Quality Dossier Program (QDP). Significant...QualitySeniorLocal area
- ...an Associate Director, Shift Quality Operations to lead real-time QA on aseptic cell... ..., investigations and CAPAs, ensuring inspection readiness and regulatory compliance across shifts while partnering... ...and experience with quality systems and data analytics to drive...QualitySeniorShift work
$136k - $170k
...across muscle, central nervous system, and cardiac diseases. In 202... ...Overview Summary: The Senior Manager, R&D Training System... ...and ensuring the accuracy and compliance of all governing SOPs. The position... ...with Corporate Compliance-Quality Systems Team to ensure training...QualitySeniorRemote work$133.8k - $200.6k
...SummaryThe Operational Area Quality Senior Manager provides... ...deviations, investigations, CAPAs, change controls,... ..., and regulatory compliance while partnering with... ...and internal quality systems.Providequality oversightfor... ...manufacturing documentation.Lead and approve...QualitySeniorFull timeContract workSummer workRemote workFlexible hours2 days per week
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