Main Purpose of the Role

Provide management of a functional area that results in the implementation and achievement of vision, mission and functional objectives. This position is responsible for overseeing and directing Quality Engineering, Supplier Quality Engineering, Regulatory Compliance, Analytical laboratories, Product release and Quality Control functions, as required, to support Manufacturing, Supplier Development, New Product Development and Quality Systems.

Plans, develops and manages the quality organisation to assure the continuance of qualified and efficient staff to meet Corporate, Food and Drug Administration (FDA), International Organisation for Standardisation (ISO) requirements as well as other regulatory requirements as captured in COP381.

Ensures the overall compliance and effectiveness of the quality system with established requirements and quality system regulations.

Directs projects to ensure the manufacture of high quality product and to facilitate compliance with requirements.

Evaluates performance of direct reports and supports career development activities. Ensures that program and project objectives are met, budgets are adhered to and metrics are captured and published.

Main Responsibilities

Recruits, coaches and develops organisational talent.
Fosters a diverse workplace that enables all employees to contribute to their full potential in pursuit of organisational objectives.
Creates an entrepreneurial environment that encourages innovation and accountability.
Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments; may supervise non-exempt employees.
Keeps the organisation’s vision and values at the forefront of decision-making and actions.
Demonstrates effective change leadership.
Builds strategic partnerships to further departmental and organisational objectives.
Develops and executes organisational and operational policies through the application of technical and professional expertise.
Monitors compliance with company policies, FDA, BSI and other applicable regulatory requirements.
Makes decisions regarding work processes, operational plans and schedules to achieve department and site objectives.
Develops, monitors and manages the annual budget for areas of responsibility.
Approves documents defining the quality system.
Reviews subcontractors’, suppliers’ and service providers’ quality systems to ensure purchased products fully comply with specified requirements.
Participates with manufacturing management at all levels in resolving quality and reliability issues.
Ensures valid test data is used for all regulatory submissions.
Oversees completion of the Annual Product Review process as required.

Minimum Requirements

Bachelor's degree (NFQ Level 7 or equivalent) in a relevant scientific, engineering, quality or related discipline.
Minimum 9 years' experience in a regulated laboratory, pharmaceutical, medical device or quality environment.
Proven people leadership experience with responsibility for coaching, developing and managing technical teams.
Strong knowledge of quality systems, regulatory compliance and laboratory operations.
Experience supporting regulatory submissions and ensuring the integrity of analytical test data.
Demonstrated experience managing audits, supplier quality activities and quality improvement initiatives.
Strong stakeholder management skills with the ability to collaborate effectively across Manufacturing, Quality and Regulatory functions.
Experience managing departmental budgets, operational plans and strategic objectives.

Quality Manager

Job Description