Quality Manager (Pharma Mechanical)

Awilli Group; Limerick; On-site; EUR 90,000 - 130,000; Full time

Job summary

Awilli Group seeks an experienced QA Manager to own quality delivery for a major biopharmaceutical construction project on a large active site. This leadership role oversees the Process Division's quality activities and ensures stringent compliance with client specs.

The role demands maintaining the Mechanical Quality Management System, development of quality plans and ITPs, and leading Field QA, NDT, and commissioning teams. Strong communication and audit skills are essential.

Qualifications

• Minimum 5 years experience in a similar QA leadership role.
• Proven pharma/biopharma sector experience is essential.
• Knowledge of hygienic piping and ASME codes.
• Experience with piping systems, P&IDs and QA software.

Responsibilities

• Maintain Mechanical Quality Management System for the project.
• Own quality delivery, ensuring client specs via quality plans and ITPs.
• Lead the project quality ethos with training and QA initiatives.
• Manage QA team including Field QA, NDT, and commissioning staff.
• Oversee QA database, handover docs, and snag resolution.
• Attend quality meetings and liaise with client and contractors.

Skills

Leadership

Quality management

Communication

Team coordination

Education

Relevant mechanical or quality qualification

Tools

Eida QA database

Microsoft Office

Job description

Our client, a leading mechanical process engineering contractor, is seeking an experienced QA Manager to join their Process Division on a major biopharmaceutical construction project. This is a large, active site and this role carries full ownership of quality delivery for the project.

This is a strong opportunity for a QA professional with genuine biopharma or pharma sector experience looking to move into a permanent leadership role on a flagship project.

Key Responsibilities

• Maintain the Mechanical Quality Management System for the project.
• Take ownership of quality delivery, ensuring all client specifications are met through accurate development and execution of project quality plans and ITPs.
• Lead the project quality ethos, embedding a "Right First Time" approach through training, quality toolbox talks, First of a Kind mock-ups, and audit and QA initiatives.
• Manage a quality team including Field QA, Test Pack Engineers, NDT Specialists, and Commissioning and Handover Supervisors.
• Manage the project quality database, ensuring it remains accurate and up to date to support client handover documentation.
• Review benchmarks and First of a Kind installations.
• Oversee development of system and equipment test packs using project quality management software.
• Liaise with the client on handover documentation, system handover, and mechanical completion dates.
• Liaise with construction teams on handover dates, walk downs, and snag lists, monitoring snag trends and driving resolution.
• Review installations for compliance with project specific quality plans, ITPs, project standards, specifications, design, and procedures.
• Manage third party inspection and NDT contractors to ensure project requirements are met.
• Oversee and complete regular site quality audits.
• Attend quality meetings with management and subcontractors, reporting on quality as required.
• Liaise with other in house specialist Mechanical QA/QC Leads as required.

Skills and Requirements

• Relevant mechanical or quality qualification.
• Minimum 5 years experience in a similar role.
• Proven experience in the pharmaceutical or biopharmaceutical sector is essential. Experience on large scale biopharma or pharma construction projects is a strong advantage.
• Knowledge of hygienic piping installation essential, including ASME codes.
• Knowledge of pharmaceutical piping systems and associated P&IDs essential.
• Knowledge of orbital welding equipment and weld procedures.
• Further quality inspection qualifications advantageous, for example Paint and Coatings.
• Proficiency in Microsoft Office essential, plus experience with large QA database systems such as Eida.
• Experience working with quality software advantageous.
• Excellent communication and interpersonal skills essential.

Work Authorisation

Candidates must have the right to work in Ireland without sponsorship. Please confirm your work authorisation status when applying.