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Inspection Readiness Remote Jobs

16 fresh jobs found

Manager, Clinical Program Quality
USA - MA - Virtual, United States

Investigational site inspections Clinical trial delivery Risk-based audit Audit Strategy Preventive Actions GCP compliance Inspection Readiness ICH GCP Corrective Actions +25

USD 108K+

Global Safety Medical Director, Rare Disease
US - California - Thousand Oaks - Field/Remote, United States

Safety analysis Safety assessments Statistical analysis plans Clinical Study Reports Medical Director Inspection Readiness Regulatory filings Evidence Generation Pharmacovigilance +26

Exec Senior Mid Full Time

USD 184K+

Associate Director, Quality Assurance - Hybrid
USA - Pennsylvania - West Point, United States

Supply chain development Molecule Development GMP manufacturing Pharmaceutics Process research Development and commercialization Regulatory Filing Large Molecule Clinical supplies +68

USD 126K+

Dir Global Clinical Program Mgt
US - California - Thousand Oaks - Field/Remote, United States

Subject recruitment Clinical program management Vendor Qualification Budgets Capacity management Operational strategy Inspection Readiness Quality Metrics Cross-functional Communication +47

Senior Mid Full Time

USD 199K+

Global Pharmacovigilance (PV) Senior Scientist
US - California - Thousand Oaks - Field/Remote, United States

Statistical analysis plans Safety Assessment Signal detection Scientific Writing Inspection Readiness Drug Safety Medical Writing Pharmacovigilance Clinical Studies +32

Senior Full Time

USD 148K+

Director of Business Operations, Clinical Operations (Office OR Remote)
Hayward, California, United States; Brisbane, California, United States; United States

Arcus Biosciences

Electronic Systems Management CAPA management Training and Onboarding Clinical trial execution Vendor oversight Internal Audits EDC ETMF Inspection Readiness +15

Exec Senior Full Time

USD 215K+

Clinical Study Associate Manager
Armonk, United States

Trial Management CFR Recruitment Strategies Inspection Readiness Good Clinical Practice Clinical Trial Management Regulatory Guidelines Microsoft Applications ICH +20

USD 108K+

Senior Manager, GCP Excellence in Clinical Trials
USA - MA - Virtual, United States

TMF Oversight TMF Documentation Process adherence Study execution Inspection Readiness Compliance monitoring Drug Development R&D Pharmaceutical Industry +21

Senior Full Time

USD 133K+

Associate Director, Quality Assurance- Validation- Hybrid
USA - New Jersey - Rahway, United States

GAMP Aseptic Processing Thermal Validation Utility Performance Qualification Equipment Validation Environmental Qualification Facility Validation Delta V Sterility Assurance +76

Senior Mid Full Time

USD 126K+

AD, Clinical Quality Assurance (Study Compliance) (Office OR Remote)
Hayward, California, United States; Brisbane, California, United States; United States

Arcus Biosciences

Veeva Quality Vault Clinical Quality Assurance Inspection Readiness SOP Development Quality Management Systems Audit Management Quality Assurance Regulatory Compliance GCP +2

Senior Mid Full Time

USD 185K+

Senior Manager, R&D Quality Operations & Excellence
Remote (US), United States

Risk-Based Quality Management ICH Requirements Internal Audits QMS Quality by design Inspection Readiness CAPA Employee stock purchase plan Audit Management +47

Senior Full Time

USD 130K+

Advisor/Senior Advisor - Regulatory Compliance and Post Market Reporting
US: USA Remote, United States

Eli Lilly and Company

Product Shortage Management Post Market Reporting Global Regulatory Reporting Inspection Readiness FDA regulations Volunteerism GMP Philanthropy Regulatory Affairs +21

Senior Full Time

USD 121K+

Global Safety Director, Obesity – US, Remote
US - California - Thousand Oaks - Field/Remote, United States

Safety assessments Safety analysis Metabolic Statistical analysis plans Obesity Clinical Study Reports Inspection Readiness Regulatory filings Evidence Generation +27

Exec Senior Full Time

USD 184K+

Senior Manager, Clinical Program Quality
USA - MA - Virtual, United States

Risk-based audit GCP compliance Preventive Actions Inspection Readiness Corrective Actions Metrics analysis Investigations R&D Stakeholder communication +23

Senior Full Time

USD 133K+

Associate Director, Clinical Program Quality
USA - MA - Virtual, United States

GCP compliance Risk-based audit Preventive Actions Inspection Readiness Corrective Actions Audit Management R&D Stakeholder communication Clinical Development +25

Senior Mid Full Time

USD 149K+

Quality Compliance Senior Manager
US - California - Thousand Oaks - Field/Remote, United States

GCP Audits Vendor Qualification Biosimilars Regulatory inspections Quality oversight Inspection Readiness Global regulations Health authorities Quality by design +50

Senior Full Time

USD 147K+

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