Audit and Inspection Manager - GxP

Role Summary

Audit and Inspection Manager - GxP located in Framingham, MA. Responsible for directing internal and regulatory audits, maintaining inspection readiness, and leading CAPA activities to ensure GMP compliance.

Responsibilities

• Developing and implementing an annual self-inspection plan
• Reviewing internal audit reports before submission to senior management to ensure accuracy and consistency
• Ensuring an inspection readiness process is in place to manage announced and unannounced inspections
• Leading and managing regulatory inspections and audits
• Identifying near misses during inspections and recommending corrective actions
• Reviewing inspection outcomes and contributing to the answers
• Monitoring the implementation of corrective and preventive actions (CAPAs) related to audit and inspection
• Managing the audit and inspection team and ensuring their proper qualification for their activity
• Representing the site in the CoP, could be a member of the CoE, and ensuring local communication

Qualifications

• 5+ years of experience in managing internal audits and external regulatory inspections, including preparation, execution, and follow-up
• Bachelor's degree in Biological Sciences or related field - preferred
• Ability to analyze complex data and audit findings to identify compliance issues and recommend corrective actions
• Meticulous attention to detail to ensure accuracy in audit reports, documentation, and compliance assessments
• Strong verbal and written communication skills to effectively liaise with regulatory bodies, present findings to senior management, and train staff
• Proficiency in managing multiple audits and inspections simultaneously, including planning, scheduling, and coordinating with various departments
• In-depth understanding of pharmaceutical regulations and standards, including Good Manufacturing Practices (GMP) and other relevant guidelines

Skills

• Regulatory compliance management
• Audit planning and execution
• CAPA tracking and closure
• Regulatory communications and reporting
• Team leadership and development
• Risk assessment and data analysis
• GMP knowledge

Education

• Bachelor's degree in Biological Sciences or related field (preferred)