Quality Risk Lead – Digital Core & Biologics GMP

Headcount Solutions Polska Sp. z o.o.

Limerick

On-site

EUR 90,000 - 120,000

Full time

7 days ago

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Job summary

Headcount Solutions Polska Sp. z o.o.

seeks a Quality Risk Management Lead to establish and embed a risk-based quality management program for a new digitally enabled biologics manufacturing facility based in Limerick, Ireland. The role will ensure that QRM is applied across facility start-up, operational resilience, digital system dependency, and paperless manufacturing continuity, partnering with Quality, Manufacturing, IT, Automation and Engineering to mitigate risks and ensure inspection

Qualifications

Extensive QRM experience in GMP-regulated pharma or biologics manufacturing.
Experience with ICH Q9(R1), digital manufacturing and system-enabled operations.

Responsibilities

Establish and manage the facility QRM program in accordance with applicable regulations and internal procedures.
Select appropriate risk assessment methods and facilitate the completion, periodic review and communication of risk assessments.
Embed risk-based decision-making across facility start-up, manufacturing, automation, data flows and quality oversight.
Ensure risk decisions are science-based, documented and inspection-ready.
Partner with Quality, Manufacturing, IT, Automation and Engineering to identify, mitigate and assign ownership of risks.
Develop and maintain the risk management plan for digital and corporate systems, including DCS, MES, eBR, ERP, data historians and network infrastructure.
Support project quality and business objectives relating to GxP risk management.