QA – Quality Risk Management Lead

The Innopharma Group; Münster; Hybrid; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Innopharma Group in Münster seeks a QA Lead with strong Quality Risk Management expertise to design and implement a risk-based quality framework for a new digitally enabled biologics facility.

You will integrate risk thinking across manufacturing, digital systems, data integrity, and continuity planning to ensure GMP compliance in a paperless environment and readiness for regulatory inspections. Experience influencing site design and governance is required.

Qualifikationen

• Extensive experience in Quality Risk Management within GMP-regulated pharma or biologics manufacturing.
• Strong knowledge of ICH Q9, digital manufacturing concepts, and system-enabled operations.
• Proven ability to operate at a strategic level, influencing site design, operating models, and quality governance.
• Experience addressing operational resiliency and business continuity in digital or paperless environments.

Aufgaben

• Develop and implement a modern, site-wide Quality Risk Management (QRM) framework aligned with ICH Q9(R1) for a digitally enabled facility.
• Integrate risk-based thinking into facility startup, manufacturing processes, digital systems, data management, and quality oversight.
• Identify, assess, and manage risks related to reliance on digital and corporate systems (DCS, MES, eBR, ERP, data historians, networks).
• Establish and manage business continuity and contingency plans to maintain GMP compliance during system outages, including paperless fallbacks.
• Collaborate with Quality, Manufacturing, IT, Automation, and Engineering to ensure risks are identified early and mitigated with clear ownership.

Kenntnisse

Quality Risk Management

ICH Q9

Digital manufacturing concepts

GMP compliance

Strategic influence

Data integrity

Ausbildung

Level 8 Degree in Science or related Discipline

Tools

DCS

MES

eBR

ERP

Data historians

Network infrastructure

Jobbeschreibung

Innopharma Technical Services, part of Innopharma Group, specialises in the training and provision of highly skilled, project-ready, Contract Engineers & Scientists to the (Bio) Pharmaceutical and MedTech Manufacturing Sector. We are seeking a QA with Strong Quality Risk Management expertise to provide support to our multinational pharmaceutical client site based in Munster province.

About the position:

The QRM Lead will help develop and implement a practical, risk-based approach to quality management for a new digitally enabled biologics manufacturing facility. The role will ensure that quality risks are identified, assessed, and managed consistently across processes, systems, and operations, with a strong focus on operational resilience, reliance on digital systems, and maintaining manufacturing operations in a paperless environment.

Key Responsibilities:

• Develop and implement a modern, site-wide Quality Risk Management (QRM) framework aligned with ICH Q9(R1) and designed to support a fully digital manufacturing facility.
• Integrate risk-based thinking into all areas of facility startup, including manufacturing processes, digital systems, automation, data management, and quality oversight.
• Identify, assess, and manage risks associated with reliance on digital and corporate systems, including DCS, MES, eBR, ERP, data historians, and network infrastructure.
• Establish and manage business continuity and contingency plans to maintain GMP compliance during system outages, such as network or cloud service disruptions, including controlled fallback processes for paperless manufacturing.
• Work closely with Quality, Manufacturing, IT, Automation, and Engineering teams to ensure risks are identified early, effectively mitigated, and clearly assigned to responsible owners.
• Ensure all risk assessments and decisions are science-based, well documented, and inspectionready, supporting regulatory confidence in a highly digital manufacturing environment.

Preferred Experience:

• Level 8 Degree in Science or related Discipline.
• Extensive experience in Quality Risk Management within GMP-regulated pharma or biologics manufacturing.
• Strong knowledge of ICH Q9, digital manufacturing concepts, and system-enabled operations.
• Proven ability to operate at a strategic level, influencing site design, operating models, and quality governance.
• Experience addressing operational resiliency, data integrity, and business continuity in digital or paperless environments.

Note:

• Due to the nature of the business, additional duties may be required from time to time.
• All applicants must be residing in Ireland, with Valid visa to work.

INNOPHARMA, RAVENSCOURT BUSINESS PARK, THREE ROCK RD, SANDYFORD, DUBLIN 18, D18 K599, IRELAND