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Director of Global GCP Inspection Excellence
2 months ago
**Job Summary:**
We are seeking a highly experienced and skilled Director of Global GCP Inspection Excellence to join our team at Lifelancer. As a key member of our organization, you will be responsible for leading our GCP inspection readiness efforts and ensuring that our research and development activities are conducted in accordance with applicable regulatory requirements, guidelines, laws, and internally established standards and practices.
Key Responsibilities:
- Lead GCP Inspection Readiness: Develop and implement strategies to ensure that our clinical study teams are inspection-ready at all times.
- Manage Inspection Logistics: Coordinate and manage all aspects of inspections, including scheduling, preparation, and execution.
- Process Improvements: Identify areas for improvement and implement changes to ensure that our processes are efficient, effective, and compliant with regulatory requirements.
- Regulatory Compliance: Ensure that our activities are conducted in accordance with applicable regulatory requirements, guidelines, laws, and internally established standards and practices.
- Team Leadership: Supervise and manage a team of quality assurance professionals, providing guidance, coaching, and mentoring to ensure their success.
- Communication: Develop and maintain effective communication with cross-functional teams, including clinical study teams, regulatory affairs, and quality assurance.
- Problem-Solving: Demonstrate ability to solve complex problems requiring in-depth evaluation of various factors.
- Quality Systems: Implement and maintain key QA systems, including investigations, Significant Quality Events (SQEs), Deviations, and CAPAs.
- Inspection Commitments: Fulfill all inspection commitments, respond to inspections, and carry out post-inspection activities, corrective and preventative actions, and resolve any issues for timely closure.
- Global Inspection Status: Manage a central repository of global inspection status and updates.
Requirements:
- Education: Bachelor's degree in a relevant field (e.g., life sciences, quality assurance, regulatory affairs).
- Experience: Minimum of 7 years of experience in GCP-related Quality Assurance function of the pharmaceutical, biotechnology, or related healthcare industry.
- Skills: Expert knowledge of relevant FDA, EU, ICH GCP guidelines; high level of understanding of international GCP requirements and standards in the pharmaceutical, medical device, and biotech industries; excellent English language skills, and additional language depending on locations and need; excellent verbal and written communication skills; ability to effectively collaborate in a dynamic environment.