Head of Quality Systems
Description
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
Head of Quality Systems
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 is responsible for supporting the establishment of comprehensive partnership frameworks with key customers and stakeholders and for leading and delivering business excellence across all area of the Quality Organization in Shanbally.
This role will include responsibility for Project Portfolio Management for the Quality team, leading and supporting the successful introduction of process improvement teams, and the optimization of systems and processes across Quality operations on the site in Shanbally.
In addition, the Job Holder is responsible for the development of partnership focused on areas such as the reducing the cost of Quality, exploring innovative concepts, and leading and supporting cross functional teams in completing ‘sprints’ which add value to the quality Organization and to the overall BioMarin Organization.
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 that are deployed by the Quality Team today.
Own and continuously improve core quality systems including, but not limited to:
- 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 effectively managed.
Provide real‑time inspection leadership, including issue triage, risk assessment, and escalation where required.
Inspection Responses & Commitments
Own the development, review, and approval of regulatory inspection responses, ensuring:
- Accuracy, consistency, and scientific soundness
- Clear root cause analysis and effective CAPA commitments
- Alignment with regulatory expectations and timelines
Lead cross‑functional teams to deliver timely, high‑quality responses and ensure commitments are tracked, executed, and closed effectively.
Act as quality approver for regulatory correspondence related to inspections and quality system commitments.
Leadership & Stakeholder Engagement
- Lead, coach, and develop quality systems team members (where applicable).
- influence and partner with senior leaders, site functions, and global quality teams to drive alignment and execution
- Act as a trusted quality advisor, balancing compliance, risk, and business needs.
Responsibilities:
- Responsible for and improve site quality systems through metrics (leading & lagging), proactive key performance indicators and process improvements.
- Lead the Quality team within Quality in delivering acknowledged value to the Quality Organization and the entire BioMarin team.
- Manage the project intake process for the Quality team in BioMarin, prioritizing and scoping the projects to facilitate the execution of selected projects.
- Work with the Quality Systems team in BioMarin Shanbally and the Corporate team to optimize the use of Data in allowing the Quality team to support the requirements of customers across BioMarin.
- Build a disruptive innovation focus across all areas of the Quality Organization to enable Quality Teams to challenge its operating model and to identify improvement opportunities to add value and to reduce the cost of Quality across the Site.
- Work with TOPS and Development Teams across the organization to build partnerships and workstreams to address existing and emerging challenges that will allow Quality to connect and support partners in delivering affordable medicines to Patients.
- Develop a comprehensive set of Lagging and Leading Metrics which will facilitate the team to track and measure its contribution across all areas of its operation.
- Lead the challenge of delivering process and governance excellence to all areas of the operation across Quality in Shanbally.
- Ensure the Shanbally site is Inspection Ready.
- Responsible for the Site QA Document Control systems.
- Support the Site Quality Lead in the development, adoption and management of a comprehensive strategy for the Quality Team in Shanbally to reach their potential in BioMarin.
- Have a strong understanding and working knowledge of GMP compliance including knowledge of EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary use, 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2.
Experience:
- 8+ year’s experience in a cGMP regulated manufacturing environment, with exhibited 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 to deliver on the objectives of the quality organization in supporting internal teams in efficient delivery of the Portfolio.
- Understanding and familiarity with FDA & 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 year’s experience in a relevant functional area.
QP qualification would be an advantage.
Supervisor Responsibility:
A team of approx. 8
Supervisor Responsibility:
A team of approx. 8
Equal Opportunity Employer/Veterans/Disabled
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.