Quality Manager / Qualified Person (QP)

Eirgen Pharma; Munster; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid working

Job summary

Eirgen Pharma is seeking a Senior Quality Leader to head QA and Quality Systems, ensuring compliance with EU GMP and regulatory expectations. The role includes acting as QP where appointed, driving CAPA, change control and continuous improvement across the site.

Hybrid policy applies: 4 days on-site and 1 day remote. You will lead cross-functional teams, manage quality risks, and partner with Operations, Regulatory, and Supply Chain to embed quality across the business.

Qualifications

• Third-level qualification in Science, Pharmaceutical or related discipline.
• 5+ years’ experience in pharmaceutical manufacturing with QA/QMS experience.
• Experience in senior quality leadership, including people management.

Responsibilities

• Lead the Quality function, QA and Quality Systems, with appropriate resourcing and governance.
• Provide strategic and operational leadership of the Pharmaceutical Quality System and regulatory compliance.
• Act as Qualified Person (QP) where appointed, ensuring batch release in line with EU GMP requirements.
• Oversee deviations, CAPA, change control, investigations, audits and data integrity.
• Lead site self-inspection programme and support regulatory inspections.

Skills

Quality Assurance

Quality Systems

Regulatory compliance

Leadership

Process improvement

Education

Bachelor's degree in Science/Pharmacy

Tools

eQMS

EDMS

LMS

Job description

Reach your career goals with Eirgen Pharma, your future could be here!

Would you like to be part of a company that has the courage, innovation, and capability to improve and enhance patient lives across the globe?

Founded in 2005, Eirgen Pharma employs over 180 people in Waterford. We combine the agility of a small company with the ambition to deliver high-quality medicines globally — all within a collaborative, people-focused culture.

About this Opportunity

Lead the Quality function within a pharmaceutical environment, with responsibility for Quality Assurance and Quality Systems.

You will be responsible for providing strategic and operational leadership to the Quality organisation, ensuring appropriate resources, ownership, governance and oversight are in place to maintain an effective and compliant Quality System.

Where appointed and authorised, the Quality Manager will act as Qualified Person (QP) in accordance with applicable legislation and EU GMP requirements.

Hybrid Policy: 4 days onsite, 1 day remote.

Key Responsibilities:

• Lead, develop and manage the Quality function, including Quality Assurance and Quality Systems, ensuring the team is appropriately resourced and aligned with business priorities.
• Provide strategic and operational leadership of the Pharmaceutical Quality System, ensuring continued compliance with cGMP, regulatory requirements, Marketing Authorisations and company standards.
• Oversee key Quality Systems including deviations, investigations, CAPA, change control, complaints, recalls, supplier quality, audits, training, data integrity and Product Quality Reviews.
• Provide Quality oversight of batch documentation, product and material disposition, product release and outsourced manufacturing activities.
• Act as Qualified Person (QP), where appointed and authorised, ensuring batch certification and release activities comply with applicable legislation and EU GMP requirements.
• Lead Quality oversight of significant investigations, compliance risks and Quality issues, ensuring effective escalation, resolution and continuous improvement.
• Lead the site Self-Inspection Programme and act as a senior Quality representative during customer and regulatory inspections, maintaining continuous inspection readiness.
• Monitor Quality performance, metrics and trends, providing updates and recommendations to Senior Management.
• Oversee electronic Quality Systems and support digitalisation initiatives that improve efficiency, governance and compliance.
• Partner with Operations, QC, Engineering, Regulatory, Supply Chain and other functions to ensure Quality and GMP requirements are embedded across the business.
• Develop team capability through coaching, performance management, succession planning and the effective delegation of Quality responsibilities.
• Promote a strong Quality and safety culture, driving risk-based decision-making and continuous improvement across the organisation.

About you

• Third-level qualification in Science, Pharmaceutical, Quality or a related discipline.
• 5+ years’ experience within pharmaceutical manufacturing, with strong Quality Assurance and/or Quality Systems experience.
• Previous experience in Quality Management or senior Quality leadership role, including people management and team development.
• Strong knowledge of cGMP, Pharmaceutical Quality Systems and applicable regulatory requirements.
• Hands-on experience across key Quality processes, including batch review and disposition, deviations, investigations, CAPA, change control and Quality Risk Management.
• Experience supporting or leading self-inspections, customer audits and regulatory inspections.
• Experience with electronic Quality Systems such as eQMS, EDMS and LMS, as well as Quality metrics, trending and Management Review.
• Strong cross-functional leadership, communication and project management skills.
• QP eligibility and/or previous QP experience is highly desirable.
• Lead Auditor training or experience would be an advantage.
• Take a key leadership role with the opportunity to shape Quality strategy, systems and culture across the organisation.
• Develop a talented Quality team while working collaboratively with senior leaders and teams across the business.