QA Systems Specialist
Location Cork, Ireland Workstyle Onsite Only ApplyWho We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
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.
QA Systems Specialist
Shanbally, Ringaskiddy, Cork ( Hybrid role 3 days per week onsite)
Closing Date: Monday 20th October 2025
BioMarin in Ireland
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.
In Ireland, BioMarin operates a Biopharma Manufacturing Site in Shanbally, Co. Cork, and a Global Commercial Operations Hub in Dublin.
What makes working here unique? At BioMarin, we feel the intense tie between the work we do and the life-changing results it delivers. Our focus on rare disease gives us the rare opportunity to truly impact lives. As BioMarin employees, we’re here because we want to be here. We enjoy our work — and each other. Our people are smart. Unassuming. Collaborative. Curious. Interesting. In return, there is development, empowerment and total reward.
ROLE
QA Systems are a multi-functional team responsible for supporting and enhancing 5# pillars onsite:
- Deviations, Change Controls and CAPA performance
- Quality Risk Management deployment
- QA Document Control
- Inspection Readiness
- Quality project portfolio management
The primary role of the QA Systems Specialist is to collaborate with internal and external stakeholders to enhance our quality systems / platforms with a focus on performance metrics / data & sponsoring change for continuous improvement.
ROLE RESPONSILBITIES
Specific goal of this role includes, but not limited to, the following:
- Enhance quality metrics generation within the scope of the 5# pillars outlined above.
- Support global alignment on quality metric initiatives.
- Develop appropriate platforms for each pillar to facilitate our partners remain compliant with procedures / systems and health authority requirements.
- Coordination of the Site Quality Review Team meeting.
- Support in the compilation of the relevant Annual Product Review memos.
- Assist in developing supplier quality management and provide quality support in supplier investigations.
- Provide support as required for inspection related activities.
- Train others in areas of expertise.
Experience Required
- Working independently and within team to meet established timelines
- Coordinate activities with others
- Readiness to support / help others with change
Competencies Required
Behavioural
- Ability to identify & escalate concerns / risks as appropriate
- Accountable for delivering on commitments
- Attention to detail
- Customer focus; takes personal responsibility for quality and accuracy of delivery
- Initiative & enthusiasm to deliver change
- Skilled communicator, both written & verbal
- Strong collaboration skills
- Successful track record in achieving goals as part of a team
Technical
- IT Applications: Microsoft teams, Power-BI, Veeva a distinct advantage
- Proficient in data analytics / visualization
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
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.