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Inspection Readiness Remote Jobs

15 fresh jobs found

Senior Clinical Trial Specialist
Boston, MA, United States

Recruitment Strategies Inspection Readiness Protocol Development Regulatory Guidelines Biopharma Supplier Management ICH Immunology Clinical operations +13

Senior Mid Full Time

USD 80K+

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

Study protocols Safety data review Signal detection Safety Assessment Obesity Statistical analysis plans Inspection Readiness Regulatory filings Pharmacovigilance +17

Senior Mid Full Time

USD 142K+

Principal Scientist, Sterile Drug Product Commercialization
USA - Pennsylvania - West Point

In-process controls Drug Product Commercialization Facility fit Shelf-life strategies Packaging strategy Site characterization Multivariate analysis CMC regulatory strategy Manufacturing science +85

Senior Full Time

USD 164K+

Clinical Trial Specialist
South San Francisco, CA, United States

Recruitment Strategies Protocol Development Inspection Readiness Biopharma Regulatory Guidelines Supplier Management ICH Immunology Clinical operations +13

Senior Mid Full Time

USD 80K+

Clinical Trial Specialist
Cambridge, MA, United States

Recruitment Strategies Protocol Development Inspection Readiness Biopharma Regulatory Guidelines Supplier Management ICH Immunology Clinical operations +13

Senior Mid Full Time

USD 80K+

GMP Compliance Expert
USA - New Jersey - Rahway

Aseptic Processing Inspection Management Pharmaceutical manufacturing Active Pharmaceutical Ingredients GMP Compliance Drug Products Manufacturing Practices Good Manufacturing Practices Inspection Readiness +43

Senior Full Time

USD 164K+

Associate Principal Scientist, Sterile Drug Product Commercialization
USA - Pennsylvania - West Point

Scale-Up Processes Drug Product Commercialization Characterization Studies Life cycle management CMC regulatory strategy Performance qualification QbD principles Manufacturing science Process Performance +93

Senior Mid Full Time

USD 135K+

Associate Director, Quality Assurance & Governance
Remote, REMOTE, United States

SOP Writing Inspection Readiness Audit Management GxP Strategic Leadership Process Development Pharmaceutical Industry Drug Development Biotechnology +15

Senior Mid Full Time

USD 142K+

Senior Manager R&D Quality Systems, Strategy, and Excellence (QMS)
Remote (US)

Corrective and Preventive Actions Quality Data Analytics Significant Quality Event Management Risk-based quality management External audits Quality by Design CAPA QMS Internal Audits +43

Senior Full Time

USD 127K+

Associate Director of R&D Quality Systems, Strategy, and Excellence (Strategy & Innovation)
Remote (US)

Quality by Design QMS Inspection Readiness Quality Management Systems GxP Quality Management System Pharmacovigilance Financial excellence ICH +39

Senior Mid Full Time

USD 134K+

Principal Scientist, Engineering
USA - Pennsylvania - West Point

Intravitreal product development Performance qualification Site characterization Manufacturing Investigations Packaging strategy Shelf-life strategies CMC regulatory strategy Multivariate analysis Tech Transfer +79

Senior Full Time

USD 164K+

Associate Principal Scientist, Engineering
USA - Pennsylvania - West Point

Manufacturing Investigations Scale-down QbD Current good manufacturing practices Tech Transfer Regulatory Filing Process Characterization DOE Process Validation +83

Senior Mid Full Time

USD 135K+

Quality Senior Manager
US - California - Thousand Oaks - Field/Remote

Imaging Methods Vendor Qualification Biosimilars Quality Metrics Quality by Design CAPA Global regulations Inspection Readiness Protocol Development +41

Senior Full Time

USD 144K+

Global Safety Officer (GSO), Global Safety Medical Director, Oncology, US-Remote
US - California - Thousand Oaks - Field/Remote

Safety analysis Statistical analysis plans Inspection Readiness Drug Safety Clinical Study Reports Regulatory filings Evidence Generation Pharmacovigilance Safety +21

Exec Mid Full Time

USD 250K+

Clinical Study Team Lead - Obesity (Director)
USA - CT - Groton

Study team operations Regulatory operations Inspection Readiness Operational strategy Outcomes Good clinical practices Internal Medicine Coverage Standard Operating Procedures +30

Senior Full Time

USD 161K+

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