Quality/Regulatory Compliance Manager

ICDS Recruitment

Mayo

Quality/Regulatory Compliance Manager - County Mayo. In this role you will be responsible for managing the GMP Quality Assurance program to assure compliance with regulatory requirements and minimise any business interruption. This role shall also assist Regulatory Affairs and Compliance management in implementing the corporate Compliance Program. Develop departmental policies and procedures to assure applicable regulatory requirements are fulfilled. Manage direct reports to ensure that Quality Assurance responsibilities of applicable regulations are fulfilled. Ensure staff receive appropriate regulatory training and mentoring to enable the execution of regulatory responsibilities. Assist in the development and presentation of regulatory training for Quality Assurance and operations staff. Schedule resources to manage compliance systems and ensure timely completion of: (1) audits of regulatory records and reports; (2) inspections of facilities and equipment; (3) investigations, (4) audits of methods, practices, and controls; (5) review/approval of SOPs and approval of Change Controls. Review and endorse Quality Assurance reports of audits and inspections to ensure proper and consistent interpretation of regulatory requirements and corporate policies. Ensure that all records and reports are prepared, communicated, and retained in accordance with applicable regulatory requirements. Meet with operations personnel to explain audit findings, resolve conflicts, and consult on corrective and preventative actions. Interface with Regulatory Agencies during inspections. Administer programs for measuring compliance and quality through pertinent metrics on key performance indicators and provide periodic reports to management. Prepare site/operation personnel for client and regulatory audits and prepare appropriate summaries and reports of such audits. Co-ordinate the preparation of regulatory and client audit responses and corrective action commitments. Track corrective actions and appraise management of their status. Ensure vendors and suppliers identified/designated by the company are assessed for the compliance with applicable regulatory requirements. Participate in Regulatory Affairs and Compliance projects and programs. Perform general auditing duties for compliance with quality standards. Prepare written reports on audit and inspection activities. Communicate all identified compliance and quality risks. Assist with Vendor Assessment, client audits and subcontractor audits. Ensure that Corporate Quality and Compliance Policies are implemented and administered at the site/operation. Manage activities of assigned group(s) to ensure optimum performance of the group/function. Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews. Assist in the development of short- and long-range operating objectives, organizational structure, staffing requirements and succession plans. Develop and oversee the implementation of departmental training programs, including orientation. Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures (SOPs, safety procedures and biosafety protocols. This job originally appeared on RecruitIreland.com.

1896 days ago