Audit and Inspection Manager

Role Summary

Audit and Inspection Manager based in Framingham, MA. Oversees the planning, execution, and oversight of internal audits and regulatory inspections to ensure compliance with GMP and related standards. Develops annual self-inspection plans, leads inspection activities, and drives CAPA follow-up.

Responsibilities

• Developing and implementing an annual self-inspection plan
• Reviewing the 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 outcome 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

• Bachelor's degree in Biological Sciences or related field - preferred
• 5+ years of experience in managing internal audits and external regulatory inspections, including preparation, execution, and follow-up
• 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

Education

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