The Director, Quality Assurance and Regulatory Compliance is an integral member of the senior management team who may be required to act as the direct interface between clients, staff and senior management team. The incumbent is responsible for the development and management of the department, ensuring that internal and external customer services provided by the company contain appropriate quality checks and quality oversight and support the professional growth and development of all staff by mentoring as well as increasing overall awareness with regard to the use of quality in processes, practices and methodologies.

It is the responsibility of the Director, Quality Assurance and Regulatory Compliance to ensure that staffs responsible for individual projects have followed the Quality Assurance (QA) practices established within the company as well as any additional regulatory guidelines applicable, but not covered in the company?s established Quality Assurance practices. In addition, the Director develops plans and strategies for sustaining and continuously improving quality related to the company?s business operations and service model, including company infrastructure qualification, disaster recovery and business continuity. Serves as a resource to management, providing reports, analysis, direction or other deliverables as needed. Key responsibilities include:

?         Identify, analyze and track system, process and cross-departmental quality issues, develop and implement corrective actions and drive change to insure resolution.

?         Review documentation for clarity, correctness, completeness and compliance and Perform verification checks of documents and clinical material prior to distribution from the company

?         Host client and agency audits and Author audit responses

?         Establish and maintain regulatory compliance framework to ensure that Almac CT?s business practice meet the regulatory requirement

?         Oversee the continuity of Quality Assurance across offices

?         Provide company wide Quality Assurance training and Participate in the training of new staff

?         Provide mechanism for professional growth and development of departmental staff

?         Develop, review and implement quality policies and processes, incorporating the areas of quality assurance and regulatory compliance, in line with company standards. 

?         Facilitate, coordinate and audit the transfer of company systems, processes and infrastructure to the NAHQ site and ensure continued quality and business continuity.

?         Provide ongoing guidance and direction to management and staff to ensure that all current and new company services and products, meet company quality standards.

?         Develop and maintain effective work relationships with staff, management, clients and other stakeholders.