Quality Manager

Purpose Statement

Provides management/support of a functional area that results in the implementation and achievement of vision, mission and functional objectives.

You will be responsible for overseeing and directing Quality Engineering and quality control functions as required to support Manufacturing.

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 Organization for Standardisation (ISO) requirements as well as other regulatory requirements as captured in COP381.

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

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.

Key Responsibilities

• Implements a staffing plan by identifying resource requirements and liaising with next level management on writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with human resources.
• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate in conjunction with next level management, and conducting formal written and verbal performance reviews.
• Monitors daily work operations and provides direction and guidance to experienced exempt employees or skilled non-exempt staff to achieve unit or project goals.
• Interacts with internal and external customers by meeting regularly, responding to requests, and explaining procedures.
• Interprets and executes policies that affect work processes and personnel within the assigned organisational unit.
• Contributes to the development of operational policies and procedures that affect personnel within the assigned organisational unit.
• Monitors compliance with company policies and procedures (e.g. FDA, ISO, Equal Employment Opportunity (EEO) regulations and standards) and escorts inspectors/auditors for third-party and unannounced inspections/audits.
• Drives continuous improvement / Corrective and Preventative Action (CAPA) and validation initiatives.
• Coordinates, where required, audits by external bodies to the site and supports audits as requested across the division.
• Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.

Education & Job Skills

1. Experience / Education

• National Framework of Qualifications (NFQ) Level 7 qualification in a relevant discipline and 4+ years of related work experience, or an equivalent combination of education and work experience.

2. Technical / Business Knowledge (Job Skills)

• Monitors progress of exempt individuals, teams, supervisors or non-exempt technical individuals toward departmental goals.
• Monitors costs of projects and of human and material resources within a department or units.
• Monitors external environment in area of technical or professional responsibility.
• Will be performing this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.

3. Cognitive Skills

• Develops and/or identifies new work processes and improved utilisation of human and material resources within the assigned area or related departments.
• Facilitates others’ involvement in the continuous improvement programme.
• Investigates and solves problems that impact work processes and personnel within the assigned unit.

4. Influence / Leadership

• Promotes attainment of group goals by selecting, motivating and training capable staff.
• Provides leadership by communicating and providing guidance toward achieving group objectives.

5. Planning / Organisation

• Schedules human and material resources in conjunction with near-term plans to ensure availability.
• Carries out operations within an established budget.

6. Decision Making / Impact

• Assignments expressed as tasks and objectives.
• Makes day-to-day decisions within established guidelines.
• Erroneous decisions could result in serious delays and substantial expenditure of time, resources and funds, without jeopardising future business activity.

7. Supervision Received

• Work is performed without appreciable direction.
• Exercises considerable latitude in determining technical objectives.
• Completed work is reviewed from a long-term perspective for desired results.

8. Supervision Provided

• Provides direction and guidance to supervisors, experienced exempt and/or skilled non-exempt employees.
• Evaluates performance and assists in career development planning.
• Often responsible for a local functional or process activity.