We are seeking a Quality Assurance Compliance Manager to lead the development and maintenance of the quality system at AbbVie North Dublin. The role will ensure compliance with applicable regulatory requirements and help ensure that products manufactured at the site meet Good Manufacturing Practice (GMP), customer, regulatory authority and AbbVie requirements.
This is a leadership role with responsibility for the site compliance programme, quality systems performance and the development of a team of quality professionals. The successful candidate will provide technical leadership, support inspection readiness and act as a key quality systems subject matter expert for the site.
Responsibilities
- Lead the Quality Assurance aspects of the site quality system, including Management Review, Corrective and Preventive Action (CAPA), Change Management, Document Management, Complaints, Training, Inspection Readiness and Management, the Self-Inspection Programme, Supplier Management, and Quality and Technical Agreements.
- Develop and manage the quality system to ensure compliance across all departments and personnel with US FDA, ICH, EudraLex and AbbVie requirements and standards.
- Prepare and maintain the Site Master File, Quality Manual and Quality Plans.
- Ensure that products manufactured at AbbVie meet the requirements of customers, regulatory authorities and the company.
- Develop and maintain quality system performance measures and report results through management review and quality performance meetings.
- Liaise with AbbVie quality and compliance colleagues, the FDA, the Health Products Regulatory Authority (HPRA) and other regulatory bodies.
- Lead regulatory inspection and corporate audit preparation for the assigned area, present technical data to stakeholders and ensure significant quality events are escalated to site quality leadership.
- Identify and lead continuous improvement and simplification initiatives, including the delivery of new quality systems initiatives.
- Champion and support the adoption of AI-enabled tools to drive process optimisation, simplification, and continuous improvement initiatives.
- Provide technical leadership and quality systems guidance to functional areas, collaborating with key stakeholders to support site goals and objectives.
- Lead, manage and develop quality professionals and direct reports within the QA Compliance group, including goal setting, performance reviews, development plans and talent management.
- Prioritise team activities in line with business needs, support timely closure of quality issues and promote a Right First Time approach.
- Act as delegate for the Associate Director, QA Compliance, as required.
- Adhere to and support all Environment, Health and Safety standards, procedures and policies.