Head of Quality Systems

Head of Quality Systems

Location: Shanbally, Ringaskiddy, Cork

Hybrid role - 4 days per week onsite

Closing Date: 8th April 2026

Summary Description

The Head of Quality Systems is responsible for maintaining and improving site quality systems, leading quality business excellence, ensuring permanent inspection readiness and site document control. The job holder supports the establishment of comprehensive partnership frameworks with key customers and stakeholders, leads and delivers business excellence across all areas of the Quality Organization in Shanbally, manages the Project Portfolio Management for the Quality team, introduces process improvement teams, and optimizes systems and processes across Quality operations. The role also focuses on developing partnership initiatives to reduce the cost of quality, explore innovative concepts and lead cross functional teams in completing value adding sprints.

The position requires thorough knowledge and experience of pharmaceutical operations, the role and reach of the Quality organization, and a strong understanding of the processes and systems deployed by the Quality Team today.

Core Quality Systems

• Deviations, CAPAs and investigations
• Change management
• Document control and records management
• Management review and quality metrics
• Training and learning systems
• Supplier quality oversight (as applicable)
• Quality risk management

Permanent Inspection Readiness

Establish and maintain a state of permanent inspection readiness across the site, embedding inspection readiness into daily operations rather than point in time preparation. Partner with functional leaders to ensure inspection readiness is understood, owned, and sustained across all departments. Serve as the site lead for regulatory inspections, including FDA, EMA, MHRA and other global health authorities.

Lead inspection planning, coordination and execution, acting as the primary quality interface with inspectors; ensure inspection logistics, documentation, SMEs and inspection rooms are prepared and managed; provide real time inspection leadership including issue triage, risk assessment and escalation. Own the development, review and approval of regulatory inspection responses, ensuring accuracy, consistency, scientific soundness, clear root cause analysis and effective CAPA commitments; align responses with regulatory expectations and timelines; lead cross functional teams to deliver timely, high quality responses and track commitments to closure; act as quality approver for regulatory correspondence related to inspections and quality system commitments.

Leadership & Stakeholder Engagement

1. Lead, coach and develop quality systems team members.
2. Influence and partner with senior leaders, site functions and global quality teams to drive alignment and execution.
3. Act as a trusted quality advisor, balancing compliance, risk and business needs.

Responsibilities

• Improve site quality systems through metrics (leading and lagging), proactive KPIs and process improvements.
• Lead the Quality team within BioMarin, delivering acknowledged value to the Quality Organization and the entire BioMarin team.
• Manage the project intake process for the Quality team, prioritizing and scoping projects to facilitate execution.
• Work with the Quality Systems team and the Corporate team to optimize the use of data to support customers.
• Build a disruptive innovation focus across all areas of the Quality Organization, challenge the operating model and identify improvement opportunities to add value and reduce the cost of quality.
• Collaborate with TOPS and Development Teams to build partnerships and workstreams to address existing and emerging challenges, enabling Quality to support partners in delivering affordable medicines to patients.
• Develop comprehensive lagging and leading metrics to track the team's contribution.
• Ensure the Shanbally site is inspection ready.
• Support the Site QA Document Control systems.
• Support the Site Quality Lead with strategy for the Quality Team to reach their potential.
• Maintain strong knowledge of GMP compliance, including EU Guidelines, 21CFR210, 211, 820, and the PICS Guide.

Experience

• 8+ years in a cGMP regulated manufacturing environment with knowledge or proficiency in Quality Assurance and Compliance.
• Ability to speak, present data and defend approaches in front of audiences and inspectors.
• Ability to lead functional and cross functional teams delivering on the objectives of the quality organization.
• Understanding of FDA and European regulatory requirements, guidelines and expectations.

Education

M.S. with at least 8 years of experience in a relevant functional area, or a B.S. with at least 10 years of experience in a relevant functional area. QP qualification would be an advantage.

Supervisor Responsibility

Team of approx. 8.

Equal Opportunity Employer

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.