Who 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.

Senior Associate - In-Market & Distribution Quality

Hybrid - Shanbally, Ringaskiddy  

Closing date Friday 20th June 2025

• Safeguarding product users against potential hazards arising from poor distribution practices, as set out in:
• EU Guidelines on Good Distribution of Medicinal Products for Human Use (2013/C 343/01).
• HPRA Good Distribution Practice of Medicinal Products for Human Use as amended.
• Meeting the requirements of an RP in accordance with EU regulations and HPRA GDP Guidance Documents as amended.
• Ensuring compliance with that the conditions of the BioMarin Wholesale Distribution Authorisation (WDA) and relevant Good Distribution Practice (GDP) guidelines.
• Ensuring a Quality Management System is implemented and maintained including quality risk management, corrective and preventative actions, change control, measurement of performance indicators and management review.
• Managing authorized activities to ensure operations do not compromise the quality of medicines and can demonstrate compliance with GDP.
• Ensuring initial and continuous training programs are implemented and maintained.
• Coordinating and promptly performing any recall operations for medicinal products.
• Co-operating with marketing authorization holders and national competent authorities in the event of recalls.
• Ensuring relevant customer complaints are dealt with effectively.
• Carrying out due diligence checks and ensuring that suppliers and customers are qualified and approved.
• Approving any subcontracted activities which may impact on GDP.
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
• Deciding on the final disposition of returned, rejected, recalled or falsified products.
• Assessing and approving any returns to saleable stock.
• Adhering to the requirements of the Falsified Medicines Directive 2011/62/EU, ensuring adequately robust procedures are in place.
• Understanding the requirements of serialization.
• Ensuring supply chain security policies and procedures are in place and adhered to.
• Demonstrating the application of activities and provisions in accordance with the BioMarin WDA and of company processes and procedures.
• Ensuring the accuracy and quality of GDP records and that relevant procedures are maintained through good documentation practices.
• Developing GDP business processes, procedures and best practices.
• Measuring performance indicators and ensuring management review of these performance indicators.
• Ensuring that any additional requirements imposed on certain products by national law are adhered to.
• Maintaining current regulatory knowledge by regularly using regulatory web sites as applicable to read any changes to guideline and regulations.
• The DRP will keep appropriate records of any delegated of duties and a formal handover will take place upon the RP’s return.
• Other duties as assigned.

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.