Inspection Readiness Manager in United States at Jobgether
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Job Description
This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Inspection Readiness Manager in United States.
This role offers an exciting opportunity to lead inspection readiness and operational quality initiatives within a highly regulated clinical research environment. You will play a critical role in ensuring global clinical trials are prepared for regulatory inspections while driving continuous improvement across quality and compliance processes. Working cross-functionally with clinical operations, quality teams, and global stakeholders, you’ll help strengthen inspection outcomes, maintain data integrity, and support the successful delivery of innovative therapies to patients. The position combines strategic project leadership with hands-on operational execution in a collaborative and mission-driven environment. It is ideal for a professional who thrives on problem-solving, process optimization, and influencing quality culture across complex clinical programs. Strong communication, critical thinking, and leadership capabilities will be key to success in this impactful role.
- 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.
- 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, including at least 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.
- Competitive annual salary range of approximately $114,745–$143,236
- Comprehensive medical, dental, and vision coverage
- Retirement and savings plans with generous employer contributions
- Life and disability insurance coverage
- Flexible spending accounts and wellness support programs
- Annual bonus opportunities and long-term incentive programs
- Stock-based compensation opportunities
- Generous paid time off and company-wide shutdown periods
- Flexible and remote work arrangements
- Career growth, mentorship, and professional development opportunities
- Inclusive, collaborative, and mission-driven work environment.