Inspection Readiness Manager
New
United StatesFull-TimeManager
Salary114,745 - 143,236 USD per year
Apply NowOpens the employer's application page
Job Details
- Experience
- Minimum 7 years of experience in life sciences or a medically related field, including at least 6 years supporting biopharmaceutical clinical research or clinical trials
- Required Skills
- Project ManagementSharePointComplianceQuality AssuranceRisk ManagementProcess improvement
Requirements
- Bachelor’s degree in Life Sciences, Nursing, or a related field, or equivalent professional experience.
- Minimum 7 years of experience in life sciences or a medically related field.
- Minimum 6 years supporting biopharmaceutical clinical research or clinical trials within biotech, pharmaceutical, or CRO environments.
- Experience managing or overseeing global clinical trial conduct and regulatory inspection readiness activities.
- Strong background in process development, quality improvement, and operational excellence initiatives.
- Previous experience in inspection management, risk management, or operational quality functions preferred.
- Solid understanding of ICH GCP guidelines, clinical trial compliance standards, and regulatory expectations.
- Excellent project management, communication, and stakeholder collaboration skills.
- Strong analytical mindset with the ability to identify risks, drive improvements, and lead complex initiatives in fast-paced environments.
- Ability to work independently while collaborating effectively across global and cross-functional teams.
Responsibilities
- Lead and oversee GCP and IVDR regulatory site inspection readiness and preparation activities across clinical trials and programs.
- Manage inspection readiness projects using tools, systems, and operational frameworks to ensure successful inspection outcomes and compliance alignment.
- Identify quality trends, operational risks, and improvement opportunities to strengthen inspection readiness processes and support continuous improvement initiatives.
- Collaborate with cross-functional teams to support study health, quality initiatives, and regulatory readiness activities across global programs.
- Serve as an advisor to business stakeholders on inspection readiness strategies and operational quality best practices.
- Maintain and manage inspection readiness documentation systems, including SharePoint platforms, regulatory preparation folders, and access controls.
- Support operational quality leadership through mentorship, knowledge sharing, and participation in strategic quality initiatives.
- Contribute to internal audits, risk management efforts, and development of innovative operational quality tools and resources.
View Full Description & ApplyYou'll be redirected to the employer's site
