Quality Manager – Pharma
Location: Wicklow, Ireland
Job Type: Full-Time | Permanent
Sector: Pharmaceutical | Engineering | M&E | EPC
Project: Major Pharmaceutical Project
The Opportunity
Zircoe Recruitment is partnering with a leading engineering contractor to recruit an experienced Quality Manager for a number of pharmaceutical projects in Wicklow.
This is a key project leadership position responsible for establishing, implementing and maintaining quality systems throughout the project lifecycle, ensuring all construction and engineering activities meet contractual, regulatory and client requirements.
Previous pharmaceutical project experience is essential for this position.
Working closely with Project Management, Engineering, Construction and Commissioning teams, the successful candidate will drive a proactive right-first-time approach to quality, ensuring issues are identified early, effectively managed and successfully closed out.
Key Responsibilities
- Lead and manage the project Quality function from mobilisation through to completion.
- Develop, implement and maintain the project Quality Management Plan.
- Ensure project activities comply with approved specifications, drawings, standards and client requirements.
- Develop and manage Inspection & Test Plans (ITPs).
- Coordinate quality inspections, audits and surveillance activities.
- Monitor construction and installation activities to ensure compliance with project requirements.
- Manage NCRs, observations, corrective actions and close-out.
- Identify quality risks and implement appropriate mitigation measures.
- Review and approve quality documentation, inspection records and test documentation.
- Coordinate quality activities across Engineering, Construction, Commissioning and Project Management teams.
- Liaise with clients, consultants, subcontractors and suppliers on quality matters.
- Conduct internal and subcontractor quality audits.
- Monitor subcontractor quality performance and ensure required standards are maintained.
- Ensure quality records are accurately maintained and fully traceable.
- Support FAT, SAT, testing, commissioning and handover activities.
- Manage quality-related aspects of project handover and close-out.
- Provide regular quality reporting to senior project management.
- Promote a strong culture of quality, continuous improvement and right-first-time delivery.
About You
We're looking for an experienced Quality professional with a strong background in major construction and engineering projects, ideally within highly regulated environments.
Essential Requirements
- Degree or equivalent qualification in Engineering, Construction, Quality Management or a related discipline.
- Significant experience as a Quality Manager or Senior Quality Engineer within construction or engineering.
- Proven pharmaceutical project experience – essential.
- Strong experience managing quality across major construction, M&E or engineering projects.
- Detailed understanding of Quality Management Systems and construction quality processes.
- Experience developing and managing ITPs, Quality Plans and inspection procedures.
- Proven experience managing NCRs, corrective actions and quality audits.
- Strong understanding of construction and engineering specifications, standards and documentation.
- Excellent communication and stakeholder management skills.
- Strong attention to detail and organisational abilities.
- Ability to manage quality across multiple disciplines and contractors.
- Strong knowledge of Microsoft Office and relevant quality management systems.
Desirable Experience
- Experience within pharmaceutical or life sciences manufacturing environments.
- Experience delivering major M&E projects.
- Experience with mechanical and electrical installations.
- Experience working within GMP-regulated environments.
- Knowledge of CQV and commissioning processes.
- Experience with cleanrooms and controlled environments.
- Experience with validation-related quality requirements.
- ISO 9001 Lead Auditor / Internal Auditor qualification.
- Quality-related professional qualification or membership.
- Experience with digital quality management and document control systems.
Key Quality Areas
- Quality Management Systems
- Pharmaceutical Construction
- M&E Quality
- Quality Plans
- Inspection & Test Plans (ITPs)
- Quality Inspections
- NCR Management
- Corrective & Preventive Actions
- Auditing
- Subcontractor Quality Management
- Construction Documentation
- Testing & Commissioning
- FAT / SAT
- Handover & Close-Out
- Continuous Improvement
- Client Quality Requirements
Project Location
Wicklow, Ireland – Pharmaceutical Projects
The successful candidate will be site-based and will play a key role in managing quality delivery throughout the project lifecycle.