Inspection Readiness Manager
Amgen
12 hours ago
Remote friendly (United States)
United States
Operations
Inspection Readiness Manager
What You Will Do
- Oversee execution of high-quality GCP & IVDR Inspection Readiness and Preparation.
- Own Site Inspection Readiness & Preparation project management for clinical trials and programs (early, late, observational).
- Develop and implement cross-functional Inspection Readiness (IR), Inspection Preparation, and Operational Quality (OQ) initiatives.
- Ensure successful regulatory inspections and high data integrity.
Additional Responsibilities
- Lead GCP & IVDR Regulatory Site Inspection Readiness and Preparation project management using tools/materials/systems; lead teams through smooth inspection experiences.
- Drive continuous improvement by identifying and acting on quality incidents/trends and updating or creating support materials/workstreams.
- Collaborate with the IR Support Team on GCP & IVDR IR, Study Health and Quality initiatives based on observations/findings and country requirements.
- Provide advisory support to the business for Inspection Readiness and participate in internal audits (limited role).
- Maintain and manage IR SharePoint (SPO) site.
- Manage Regulatory Inspection Preparation folders and access.
- Support the Inspection Readiness & Operational Quality Senior Manager.
- Provide mentorship to student interns.
Qualifications/Skills (What We Expect Of You)
- Bachelor’s degree in Life Sciences or RN or equivalent.
- 7 years experience in life sciences/medically related field, including 6 years biopharmaceutical clinical research experience on clinical trials at a biotech, pharma, or CRO.
- Experience/oversight of global clinical trial conduct.
- Experience driving and leading process development and/or improvement.
- Inspection or Risk Manager experience (preferred).
Application Instructions
- Submit your CV along with a cover letter for consideration.
Benefits (if explicitly listed)
- U.S. annual base salary range: $114,745–$143,236.
What You Will Do
- Oversee execution of high-quality GCP & IVDR Inspection Readiness and Preparation.
- Own Site Inspection Readiness & Preparation project management for clinical trials and programs (early, late, observational).
- Develop and implement cross-functional Inspection Readiness (IR), Inspection Preparation, and Operational Quality (OQ) initiatives.
- Ensure successful regulatory inspections and high data integrity.
Additional Responsibilities
- Lead GCP & IVDR Regulatory Site Inspection Readiness and Preparation project management using tools/materials/systems; lead teams through smooth inspection experiences.
- Drive continuous improvement by identifying and acting on quality incidents/trends and updating or creating support materials/workstreams.
- Collaborate with the IR Support Team on GCP & IVDR IR, Study Health and Quality initiatives based on observations/findings and country requirements.
- Provide advisory support to the business for Inspection Readiness and participate in internal audits (limited role).
- Maintain and manage IR SharePoint (SPO) site.
- Manage Regulatory Inspection Preparation folders and access.
- Support the Inspection Readiness & Operational Quality Senior Manager.
- Provide mentorship to student interns.
Qualifications/Skills (What We Expect Of You)
- Bachelor’s degree in Life Sciences or RN or equivalent.
- 7 years experience in life sciences/medically related field, including 6 years biopharmaceutical clinical research experience on clinical trials at a biotech, pharma, or CRO.
- Experience/oversight of global clinical trial conduct.
- Experience driving and leading process development and/or improvement.
- Inspection or Risk Manager experience (preferred).
Application Instructions
- Submit your CV along with a cover letter for consideration.
Benefits (if explicitly listed)
- U.S. annual base salary range: $114,745–$143,236.