Project Manager

Desired Skills: Project Management,Supply Chain,GMP,Quality Systems,Lean,SAP,Change Controls

Role Summary

The Quality Manager – Projects Compliance is accountable for GMP compliance governance of Supply Chain–related capital and warehouse projects at our Dun Laoghaire site. This role serves as the primary Supply Chain owner for quality system activities associated with projects, including change controls, deviations, risk assessments, CAPAs and GMP documentation updates.

The position partners closely with Supply Chain, Quality, Projects and Operations to ensure projects are executed in full compliance with our Quality Systems, regulatory expectations and site procedures. This is a hands-on delivery role requiring strong project management capability, technical depth and the ability to lead cross-functional teams in a regulated environment.

Key Responsibilities

Change Control & Project Compliance Leadership

• Act as Supply Chain compliance lead for internal and external warehouse capital projects.
• Own end-to-end management of Supply Chain Change Controls, including:

o          Development and maintenance of project plans, timelines and milestones

o          Identification of resource requirements and cross-functional dependencies

o          Critical path analysis, sequencing of activities and risk mitigation

• Ensure all project-related changes meet GMP, regulatory and company Quality requirements and are executed and closed on time.

Deviation, CAPA & Risk Management

• Own and lead Supply Chain Major Deviations and selected Minor Deviations, including:

o          Investigation leadership and root cause analysis

o          Assessment of product impact and compliance risk

o          Definition, implementation and effectiveness verification of CAPAs

• Provide technical guidance and oversight to Supply Chain colleagues managing Minor Deviations and CAPAs.
• Author and manage Quality Risk Assessments (e.g. FMEA) related to Supply Chain projects and operational changes.

GMP Documentation & Process Governance

• Lead development, review and update of Supply Chain SOPs and controlled documents to support new or modified processes.
• Develop and execute protocols to support:

o          Change controls

o          Deviations and investigations

o          Project troubleshooting and implementation activities

• Ensure documentation is compliant, inspection-ready and aligned with global standards.

Quality Oversight & Performance Monitoring

• Maintain oversight of Supply Chain quality system metrics, including:

o          Change controls

o          Deviations

o          CAPAs and CAPA effectiveness verifications

• Perform trend analysis and proactively identify compliance risks.
• Ensure appropriate escalation to management where timelines, compliance or delivery are at risk.

Audit & Stakeholder Engagement

• Support internal and external audits and regulatory inspections, responding to questions related to Supply Chain projects, deviations and change controls.
• Collaborate with Supply Chain sub-functions (Warehouse Operations, Warehouse Support, Master Data & Procurement, Planning teams), Quality, Manufacturing and Engineering.
• Engage with global Supply Chain network partners to ensure alignment and consistency.
• Perform additional duties as assigned by Supply Chain leadership.

Basic Qualifications

• Bachelor’s Degree in Science or Engineering and 5+ years’ experience in biotech/pharma manufacturing or manufacturing support

OR

Preferred Qualifications

• Demonstrated experience leading GMP change controls, deviations, CAPAs and quality risk assessments.
• Strong project management experience in a regulated environment with multiple concurrent priorities.
• Proven ability to lead cross-functional teams and influence stakeholders.
• Excellent technical writing, documentation and presentation skills.
• Experience interacting with regulatory agencies and auditors.
• Lean / Six Sigma Yellow Belt or higher.
• Working knowledge of SAP ERP within Supply Chain operations.
• Experience supporting capital projects in GMP warehouse or Supply Chain environments.

Please click the link below to apply or alternatively send an up-to-date CV to howie.leahy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***