Associate Director, QA Compliance

Careerwise Recruitment

Carlow

An Associate Director, QA Compliance, is required by CareerWise Recruitment for our Leinster based Biologics client. This role will manage a team of Quality Assurance Specialists and Senior Specialists. They will be responsible for all people aspects, such as coaching, talent development, recruitment and performance management. THE ROLE: * Serve as primary contact for regulatory agency inspectors. Lead the development of responses, CAPA implementation and effectiveness checks. * Manage the site auditing program. * Ensure recalls are executed as decided and appropriate agencies and contacts are notified in accordance with defined procedures. * Ensure that all regulatory commitments and related reporting are generated and submitted to the appropriate department or Regulatory Authority in accordance with established procedures. * Verify data and information in regulatory submissions and regulatory responses for quality, integrity and accuracy. * Manage site quality agreements with external and internal partners in line with established procedures. Contribute to the creation of quality agreements for multiple sites or on global level for such quality agreements that are relevant for the site. * Ensure that a system is in place to manage CAPA activities including generation, investigation, documentation, implementation, verification, closure, effectiveness, and trending. * Ensure that a system is in place to manage complaints handling and investigations and ensure its effectiveness. * Oversee and manage all data integrity activities of the site. REQUIREMENTS: * Third level qualification (Degree) in a Science or Technical related discipline. * Project Management qualification such as, Project Management Professional. * Minimum of 10 years' experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in quality and/or manufacturing * Significant leadership experience in a front-line supervisory role in operations environment. * Demonstrated in-depth knowledge of global health authority regulations and quality and compliance requirements with the ability to effectively communicate th. * Ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives. Please call Brian Flynn today for further information on 021 4297423 or email: bflynn@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. This job originally appeared on RecruitIreland.com.

2050 days ago