Audit & Compliance Manager – Sterile

Regulatory Compliance Ensure site-wide compliance with all applicable regulations, including cGMP, FDA, EMA, MHRA, and other global regulatory standards for sterile manufacturing. Maintain up-to-date knowledge of regulatory changes, guidance documents, and industry trends to ensure ongoing compliance. Act as the site subject matter expert for audit and compliance-related matters. Audit Management Plan, lead, and execute internal audits to assess compliance with SOPs, quality systems, and regulations. Develop and implement corrective actions to address non-compliance issues. Collaborate with cross-functional teams to ensure compliance with company policies and procedures. Provide training and support to employees on regulatory requirements and expectations. Ensure compliance with industry standards and best practices. Maintain accurate records of audits, findings, and corrective actions. Identify opportunities for process improvements and implement changes as needed. Develop and maintain audit schedules and plans. Coordinate and facilitate external audits and inspections. Ensure timely and effective resolution of audit findings and recommendations. Provide regular updates to management on audit status and results. Develop and maintain a comprehensive compliance program that includes training, awareness, and communication activities. Ensure compliance with company policies and procedures related to auditing and compliance. Develop and implement a corrective action plan to address non-compliance issues. Coordinate and facilitate internal audits and inspections. Ensure timely and effective resolution of audit findings and recommendations. Provide regular updates to management on audit status and results.