Regulatory Inspection Lead
Company Description
QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!
Job Description
The Regulatory Inspection Lead to the Quality Assurance department. This position is the responsibility for reviewing, analyzing, and tracking inspection-related documentation to ensure timely and compliant responses to regulatory observations
Key Responsibilities:
• Lead the implementation of quality-related projects aimed at enhancing inspection readiness and operational excellence.
• Review and interpret inspection reports, regulatory observations, and related documentation to identify compliance gaps and areas for improvement.
• Monitor investigation timelines and escalate delays to relevant stakeholders to ensure timely closure and regulatory compliance.
• Support the Management Review process by preparing inspection-related metrics, tracking overdue actions, and identifying systemic issues.
• Collaborate cross-functionally to ensure CAPAs and investigation responses meet internal quality standards and external regulatory expectations.
• Provide strategic input into quality system improvements based on inspection trends and findings.
Qualifications
• Bachelor’s degree in Life Sciences, Engineering, or related field.
• Minimum 10 years of experience in the pharmaceutical industry, with a strong background in Quality Assurance, Quality Systems, or Regulatory Compliance.
• Proven experience in Business Excellence, Quality Implementation, and Project Execution.
• Deep understanding of GMP, FDA, EMA, and ICH guidelines.
• Strong analytical and organizational skills with attention to detail.
• Excellent written and oral communication skills.
• Proactive mindset with a focus on problem-solving and driving accountability.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Average salary estimate
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