GxP Document Control & Quality Systems Lead
Bicara Therapeutics
Bicara Therapeutics is seeking a Manager, GxP Document Control to oversee and continually improve document control operations and quality systems coordination. You will lead cross-functional teams to balance speed, accuracy, and compliance, coaching authors and reviewers on clear, audit-ready procedures. The role is based in our Boston office with a hybrid schedule (three in-office days per week). You will also support training administration, vendor coordination, and quality systems activities #J-18808-Ljbffr Bicara Therapeutics
$151.2k - $226.8k
...framework to ensure processes, document control, training, and quality records support consistent... ...harmonization across GxP domains (GMP/GLP/GCP) and... ...items, training compliance)Lead QMS simplification/optimization... ...ISO Lead Auditor, Quality Systems)Training in electronic QMS...Quality- ...porcine kidney, is the Company’s lead program and is currently... ...SUMMARY The Senior Quality Systems Specialist will be supporting... ...Methods Responsible for Documentation Management (archival of physical... ...of Document Change Controls etc.) Responsible for Organization...Quality
- ...Description Job Description The Associate Director, Quality Systems leads the strategy, design and continuous improvement of... ...operations. The role owns core quality systems, including document management, change control, deviations, CAPA, training, supplier quality, and...QualityWork at officeMonday to Friday3 days per week
$107.5k - $204.5k
...experienced and motivated Hardware Lead to join our Air Traffic Systems (ATS) team. The... ...next generation Air Traffic Control (ATC) and Weather Data... ...including Software, Systems, and Quality to deliver integrated... ...(BOE) writingExperience documenting and implementing...QualityContract workTemporary workWork experience placementStart working todayWork at officeRemote workFlexible hours$200k - $260k
...vision is to build a world leading oncology company... ...Director/Senior Director, Quality Management Systems (QMS), Digital Quality Assurance and GxP Compliance to be a key... ...System, including document management, training,... ...approaches, and change control governance. Lead continuous...QualityContract workTemporary workFlexible hours$160k - $195k
...and the central nervous system (CNS) to address the... ...The Associate Director, Quality Management Systems is... ...of the QMS including document control, records management and... ...Inspection Readiness Leads the evolution of the QMS... ...leadership for GxP documentation and training...QualityLocal area$90k - $180k
...RoleRole OverviewWellington Management is seeking an experienced Lead Systems Analyst to join the Portfolio Analysis Technology team within... ...investor workflows and analytical needs into scalable, high-quality technology solutions that support the firm’s global investment...QualityFull timeRemote workFlexible hours1 day per week$160k - $185k
...Integration Architect, Finance Systems AutomationAbout AcrisureA... ...Workday Integration Architect leads the design, development, and... ...fostering growth and ensuring quality delivery.Project Oversight: Lead... ...platforms or API’s and document the design in accordance with...QualityFull timeImmediate startRemote workFlexible hours- ...Pharmaceuticals seeks an Associate Director of Quality Management Systems to oversee GxP quality systems, including document control, records management, and exception handling.... ...expert for eQMS and eDMS platforms Lead weekly quality event review meetings and track...Quality
$186k - $200k
...investigational medicines, anchored by its lead product, ARCALYST, the first and only... ...need it most.The Associate Director, Quality Management Systems (QMS) is responsible for the site's GxP quality systems, including Document Control, Records Management, and Exceptions...QualityWork at office$193k - $261k
...calling to “Reimagine Possible”, we are leading the charge toward a world in which... ...disease.Description: The Director, Quality Systems (QS) leads the internal team at... ...for foundational quality processes: GXP Training, Document Control, Vendor Management, and Wave’s...QualityContract workTemporary workSummer workLocal area$90k - $180k
...because we believe multiple perspectives lead to more informed investment and business... ...Management is seeking an experienced Lead Systems Analyst to join the Research Technology team... ...and research needs into scalable, high-quality technology solutions that support the...QualityFull timeRemote workFlexible hours1 day per week- ...experienced Computer System Validation (CSV) Lead to oversee... ...systems used in regulated GxP environments. The ideal... ...compliance, validation documentation, risk assessments,... ..., CAPAs, change controls, and periodic reviews... ...activities with IT, Quality Assurance, Engineering...Quality
- ...Description QC Laboratory Systems Analyst – GxP / CSV– 100% On Site – W2 Only... ...Site Functions – Quality, Validation and Product... ...application to help author SDLC documents, including SDCS, URS, FRA,... ...– CAPA, Deviation, Change Control o Veeva – Document Workflows...QualityContract work3 days per week
$95k - $130k
...Engineering is seeking an experienced, hands-on Quality Lead to lead and own the company's Quality Management System (QMS) within a regulated medical device... ...reportability decisions. Maintain and administer document control, change management, and training systems....QualityFull timePart timeWork experience placementWork at office$39 - $48.02 per hour
...About the Opportunity A leading healthcare organization is... ...environment while supporting high-quality patient care and mentoring... ...department. Perform and document quality control, quality assurance, and... ...laboratory information systems (LIS) is preferred. Excellent...QualityHourly payPermanent employmentTemporary workBank staffLocal areaRelocation packageMonday to FridayShift work- Prime Medicine in Cambridge, MA is seeking a Senior Quality Engineering Specialist to provide hands-on support for GxP software, equipment qualification, calibration,... ...activities, maintain records, and ensure systems are inspection-ready. A Bachelor's degree and at...Quality
$130.8k - $209.4k
The RoleThe GxP Endpoint Engineer will serve... ...align with Quality Assurance (QA) guidance... ...operating system deployments, in-place... ...engineer will define and document GxP configuration... ...implement quality-controlled deployment... ...aspired to build the leading mRNA technology platform...QualityPermanent employmentFull timeWork at officeWork from home$116k - $182.27k
...Description Job Title: Lead Clinical Study Manager (Lead... ...objectives in compliance with quality standards (including ICH GCP,... ...protocol and other study related documents. Challenges study... ...updates of budget and financial systems are accurate. Communicates study...QualityMinimum wageFull timeContract workFor contractorsLocal areaRemote workFlexible hoursNight shift- ...Takeda Cambridge seeks a Director, Business System Owner – Veeva RIM to define and deliver... ...and data governance. You will lead cross-functional teams, drive governance,... ...establish KPIs to measure value and data quality across a global matrix, in a hybrid Massachusetts...Quality
- Anduril Industries seeks a Lead R&D Technician to orchestrate daily activities for a team of R&D technicians in the build, troubleshooting... ...to meet evolving requirements. You will drive safety, quality, and timely completion of builds, guiding the team under demanding...Quality
- ...Description Summary/Objective : The Lead Superintendent oversees the full scope... ...Safety, QA/QC, Subcontractor Management, Document Control, Schedule, Relationship Management & Project... ...field and is expected to turn out high-quality work in the largest possible quantities...QualityContract workFor subcontractorWeekend work
$228k - $342k
...DescriptionSenior Director, Quality Data, Digital Systems & ComplianceGxP Data... ...models and operations across GxP Data Integrity, Data Governance... ...oversight. The position promotes leading practices, supports... ...quality standards, metrics, controls, and monitoring processes.Embed...QualityFull timeWork experience placementSummer workRemote workFlexible hours2 days per week- ...Senior Director role leading enterprise-wide GxP data governance, data integrity, master data management, computerized systems compliance, and quality analytics. This strategic position partners... ...data quality standards, metrics, controls, and embed proactive...QualityWork experience placement
$319.06k - $389.97k
...More:The Vice President of Quality Management Systems is responsible for defining... ...This role will develop and lead a high-performing quality team... ...Deviations, CAPA, Change Control, Document Control, Complaints,... ...innovationPartner with IT leadership on GxP computer systems lifecycle...QualityFull time$161.5k - $242.3k
...Associate Director, GxP Operations Support Manufacturing Systems will provide... ...and manufacturing control system platforms supporting... ...Manufacturing, Quality, Validation,... ...improvement of procedures, documentation, training programs... ...track record leading cross-functional initiatives...QualityFull timeSummer workFlexible hours$114.1k - $211.9k
...an experienced Supply Chain and Logistics Lead to join Mariana’s Technical Operations... ...supplier performance to ensure reliability and quality.Logistics Management:Manage... ...using supply chain management software and systems.Outstanding communication and interpersonal...QualityWork experience placement$178.5k - $257.83k
...As Global Periodic Reporting Lead within our Pharmacovigilance... ...develop robust , compliant, and controlled processes for Periodic Safety... ...understanding of the immune system - and innovative pipeline -... ...wellbeing benefits including high-quality healthcare, prevention and...QualityFull timeWorldwide$130k - $170k
...performance for life.WHOOP is hiring a Senior Lead, DTC Commercial Planning & Strategy to... ...to build out the commercial operating system of the DTC business (planning, forecasting... ...-assisted work aligns with the same high-quality standards as personal contributions.This...QualityFull timeWork at officeRelocation$175k - $265k
...THE COMPANY PAX is a leading global cannabis brand... ...the Head of Product Quality, you will build, scale... ...'s Quality Management System (QMS) while serving as... ...authority, oversee design controls and risk management (... ...risk files are living documents, updated through the...QualityContract work
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