- Twist BioScience (South San Francisco, CA)
- …MES, ensuring scalability, maintainability, and alignment with biomanufacturing strategy, GxP regulations, industry best practices, and technological advancements in ... and quality reviews.Compliance & Validation: Ensure our custom MES solutions comply with GxP regulations (eg, cGMP, GLP), FDA 21 CFR Part 11, Eudralex Annex 11,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …role in overseeing the development, validation, implementation, and integration of GxP -regulated systems across the organization. This position ensures that all ... for defining and driving the methodology, approach, and best practices for GxP systems while ensuring alignment with the Global Digital Transformation (DX) strategy,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Compliance, GCP/Document Audits supports end-to-end audit activities per audit program of GxP relevant audit activities for the Daiichi Sankyo's GxP group and ... organization and affiliates as appropriate for the area of GxP audits assigned. Support conduct of document audits including...studies and vendors as applicable for the area of GxP audits assigned in alignment with the Master Audit… more
- Aequor (Athens, GA)
- …comply with FDA/EU and Good [Laboratory, Clinical, Manufacturing] Practice ( GXP ) regulations and guidelines. Accountabilities: Prioritizes and performs routine and ... to perform work according to national codes, site/corporate policies and procedures, and GXP regulations as applicable. Basic level of understanding of USDA and EMEA… more
- BioAgilytix (San Diego, CA)
- …a team of scientists through assay development, validation, and sample analysis under GxP , while also playing a key role in client engagement, project delivery, and ... of regulatory guidance to experimental planning and design Experience working in GxP environments and demonstrated knowledge of GxP regulations Supervisory… more
- BioAgilytix (San Diego, CA)
- …control, data integrity), following 21 CFR Part 11, Annex 11, GxP , and GAMPCompletes periodic reviews of validated computer systemsPerforms administrative tasks ... validationMinimum Preferred Qualifications: SkillsProficiency in Computer System Validation, following GxP regulations and GAMP guidelinesAdvanced knowledge of Active Directory,… more
- BioAgilytix (Durham, NC)
- …processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP , GDPR, and FIRPA.Design data quality KPIs and implement initial quality ... data integrity in alignment with regulatory frameworks such as HIPAA, GxP , GDPR, and FERPA.Preferred Technical SkillsProficiency in designing, building, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …interfaces in scope, including PI support with LSPs/3PLs.Responsible for documenting all GxP changes in scope, in line with industry standards and regulations, by ... managing internal and external suppliersGood documentation skills, familiar with GxP requirementsResult-oriented, flexible and reliable TravelAbility to travel up to… more
- Formation Bio (New York, NY)
- …vendor compliance with company policies, industry regulations (eg, FDA, EMA, GxP ), and data security requirements. Identify opportunities for cost savings, contract ... optimizations, and risk mitigation. Implement procurement analytics and reporting tools to provide visibility into vendor spend and procurement trends. Stay informed of industry trends, supplier market dynamics, and regulatory changes impacting procurement.… more
- Merck & Co. (Lower Gwynedd, PA)
- …handlers to perform preclinical and clinical assays is preferred.Experience with GxP as it applies to regulated bioanalysis.Current Employees apply HERE Current ... Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the… more
- Novo Nordisk Inc. (Durham, NC)
- …to collaborate in a team environment required Pharmaceutical industry experience ( GxP ) preferred Data Visualization with Tableau experience required Experience in ... applying systematic and rigorous analytics methods to improve data-related business processes required Strong IT Knowledge, demonstrating ability to handle most situations independently and with minimal guidance required Ability to identify better practice and… more
- Merck & Co. (Rahway, NJ)
- …to prepare Standard Operating Procedures (SOP) and current GXP documents.Experience with quality systems.Excellent organizational skills.Desire and willingness ... to learn, contribute and lead.Track-record of independent problem-solving. Preferred Experience and Skills: Experience with sterile GMP facility startup.Knowledge of Investigational drug regulatory requirements.Understanding of Clinical Supply Chain… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in quality assurance, manufacturing compliance, clinical quality, or cell therapy. GxP Quality System knowledge, including relevant regulations and guidances (eg ... 21 CFR parts 210, 211, 1271, 600, 601, 610, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).Strong written and verbal communication, analytical problem solving and conflict resolution skills.Flexible, highly motivated, with strong organization skills,… more
- BioAgilytix (Durham, NC)
- …is ideal for someone with a strong background in method development, GxP -compliant validation, and targeted and untargeted analysis using chromatography and mass ... spectrometric platforms.At our organization, we're dedicated to pushing the boundaries of analytical science. Our LC/MS team leverages the synergy between liquid chromatography (LC) and mass spectrometry (MS) to revolutionize how we understand and quantify… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in supporting cell-based products is a plusStrong knowledge of GxP complianceExperience in cGMP regulatory body auditsStrong interpersonal and written/oral ... communication skillsAbility to quickly process complex information and make critical decisions with limited informationAbility to work independently and be responsible for a portfolio of ongoing projectsAbility to pay attention to details and follow procedures… more
- Tris Pharma (Monmouth Junction, NJ)
- …management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory agency procurement policies and ... procedures throughout the organization. Ensures compliance with all current GxPs, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and Occupational Health and Safety Administration (OSHA) regulations, as well as all applicable company… more
- Eisai, Inc (Nutley, NJ)
- …area Strong analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. ... Ability to Travel (approximately 15%)This role is hybrid and requires at least 2 days per week working onsite in our Nutley, NJ office. Eisai Salary Transparency Language:The base salary range for the Director, Clinical Quality Assurance is from… more
- Ionis (Carlsbad, CA)
- …while you develop and expand your career! MANAGER / SENIOR MANAGER - GXP QUALITY SYSTEMS (QA VENDOR MANAGEMENT) SUMMARY: We are seeking an experienced Manager ... role is for an individual contributor reporting to the Assistant Director, GxP Quality Systems (QA Vendor Management). Primary responsibilities will focus on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience in quality management in the pharmaceutical industry and quality ( GxP ) requirements Experience with process mapping, process redesign and SOP ... authoring/coordination (Required)3 or more years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required)2 or more years with experience working with international teams; strong… more
- Cleared Jobs (Tampa, FL)
- …GEOINT 35G Technical SchoolOperating ArcGIS and Remote View, SOCET GXP or similar softwareActive In-Scope TS/SCI ClearancePreferred QualificationsDesired Education: ... of GEOINT 35G Technical SchoolOperating ArcGIS and Remote View, SOCET GXP or similar softwareActive In-Scope TS/SCI ClearanceInterpret and analyze GEOINT observables… more
