QA Systems Technical Manager
Description
Who We Are
BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with multiple commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients..
About Technical Operations
Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Shanbally, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.
QA Systems Technical Manager
QA Systems
Onsite Role - Shanbally, Ringaskiddy, Cork
Closing Date: 15th May 2026
- Act as a business process manager for applicable quality systems.
- Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures in conjunction with the accountable parties.
- Work with key stakeholders to identify and implement system improvements
- Analyse performance through metrics and trending
- Troubleshoot issues and support the business with queries
- Benchmark leading practices & identify opportunities to enhance systems
- Liaise with global colleagues to share learnings to ensure consistency across the network and alignment with global processes.
- Lead a team of specialists, associates and contingent workers within the Quality Systems and Compliance team. Responsibilities include talent acquisition, performance management, budget proposals, inspection preparedness and strategy development.
- Provide Quality Assurance review and/or approval for Supplier Management related activities impacting GxP operations at BioMarin, including and not limited to Changes, Deviations, Specifications and Technical Agreements.
- Provide additional support to Quality Systems and Compliance team:
- Support audit and inspection activities for site.
- Lead activities associated with the site quality management review process.
- Other duties as assigned.
- Bachelor’s degree in Pharmaceutical Sciences, Process Engineering or related discipline.
- 10–15+ years experience within GMP-regulated pharmaceutical or biotechnology environments
- 3-5 years in leadership roles, with experience in people management and a proven ability to influence cross-functional teams and stakeholders.
- Significant hands-on experience supporting regulatory inspections.
- Knowledge of EU GDP Guidelines and regional regulatory requirements.
- Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk
- Excellent communication and influencing skills across all organizational levels.
- Planning and organising skills.
- Detail-oriented, analytical thinker.
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.