Reporting to the Sr. Director, Global GCP Inspection Excellence, the inspection lead will be primarily responsible for GCP Health Authority inspection readiness for cross-functional clinical study teams, managing inspection logistics and process improvements to ensure research and development activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards and practices.

Tasks Requirements:

• Supervise and manage activities related to inspection readiness, leading inspections conducted by regulatory health authorities such as FDA, EMA, CFDI, MFDS, PMDA, TGA, etc.
• Collaborate with cross-functional clinical study teams to ensure a unified approach to inspection readiness strategy.
• Manage Inspection Readiness Checklist, development of storyboards, identify and mitigate inspection risks, and facilitate/lead mock and actual inspections.
• During inspections, assign inspection requests to appropriate subject matter experts (SMEs) and provide guidance to ensure timely fulfillment.
• Create/revise appropriate SOPs and tools for inspection readiness and management.
• Implement and maintain key QA systems, including investigations, Significant Quality Events (SQEs), Deviations, and CAPAs.
• Demonstrate ability to solve complex problems requiring in-depth evaluation of various factors.
• Fulfill all inspection commitments, respond to inspections, and carry out post-inspection activities, corrective and preventative actions, and resolve any issues for timely closure.
• Manage a central repository of global inspection status and updates.
• Meticulous attention to detail, excellent reviewing skills, and ability to independently manage multiple tasks in a fast-paced environment.
• Support/manage pre-inspection visits at investigative sites.
• Lead and manage lessons learned sessions after inspections, identifying trends and best practices to implement process improvements.
• Proven ability to set strategies for and drive initiatives aimed at improving quality processes.
• Strong leadership skills and ability to mentor others.
• Thorough understanding of international regulations applicable to the conduct of clinical trial operations on a global scale.

Supervisory Responsibilities:

This position may include managing staff: coaching and mentoring of junior staff with training/orientation/qualification and development plan for new Quality staff when required. Therefore, it is required to have strong leadership experience and mentoring skills.

Qualifications:

• BA/BS degree required
• Expert knowledge of relevant FDA, EU, ICH GCP guidelines
• Minimum of 7 years of experience in GCP-related Quality Assurance function of the pharmaceutical, biotechnology or related health care industry.
• 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.