Manager, GMP Inspection Management

Job Responsibilities

• Leads site inspection readiness efforts about preparing the Indianapolis site for health authority inspections and internal corporate audits.
• Develops and manages the Inspection Readiness annual plan, including identification of anticipated inspections.
• Participates as a core team member in any corporate or health authority inspections and leads cross-functional teams to develop responses, tracking the commitments to completion.
• Responsible for RayzeBio Self-Inspection Program.
• May conduct audits of RayzeBio departments relative to RayzeBio policies and procedures as well as the relevant Health Authority requirements.
• Leads Regulatory Surveillance activities, including identifying impacted functions, driving impact assessments and proactive action plans.
• Provides compliance expertise and guidance to the site on applicable regulatory, cGMP and corporate requirements.
• Supports regulatory agency correspondence and filing submission activities.
• Led Fact Finding deliverables for significant events and supports Field Alert Reporting submissions as required.
• Leads APQR document coordination and authoring support for site.
• Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
• Provides oversight to identify and implement changes that lead to realization of long-term department and company goals.

Requirements

• A bachelor's degree in engineering or a life or physical science related field (including biology, biochemistry, chemistry).
• Minimum 5-7 years of work experience in Quality Assurance and minimum 4 years of direct QA experience in leading/hosting/conducting GMP audits/inspections.
• Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing.
• Knowledge of US, EU and rest-of-world cGMP regulations and guidance.
• Knowledge and proven experience in hosting/facilitating FDA, EMA, or other regulatory authority inspections.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Excellent writing and oral communication skills are required.
• Previous work responsibility, which required a high degree of attention to detail.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills.

Education

• At minimum, a bachelor's degree in engineering or a life or physical science related field (including biology, biochemistry, chemistry).