Training & Compliance Specialist

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.

Training & Compliance Specialist

Hybrid - 3 Days Onsite

Shanbally, Ringaskiddy Cork

Closing date 6th March

The Role:

The Training & Compliance Specialist will perform functional administration activities on learning systems and reporting tools for various training functions, including Quality, Manufacturing and Supply Chain.

What you will do:

Business Partnership

• Partner with Department Team Leads and related personnel, to assess training needs for their functional area(s) of responsibility; assist in translating needs into training requirements/solutions.
• Partner with various functional groups (e.g., Manufacturing, Quality, Regulatory, Compliance, HR, etc.) to incorporate functional-based training programs into the role-based curriculums, as appropriate.
• Own and support actions for Deviations/CAPAs related to the Training System and LMS.
• Investigate, or recommend systemic improvements to the training system.
• Represent LMS processes during regulatory body audits/inspections and support requests for training records and/or evidence for qualification.
• Document training records and manage assignment requests in learning management system(s)
• Support Learning and Development Improvement Projects as required.
• Create and manage job aids and work instructions as they relate to the LMS and Training processes
• Provides back up support and coverage to other Training Compliance Specialists
• Contribute to Training Website and Webpages – curating content and maintaining site contents and calendar(s)
• Provide troubleshooting support for LMS assignments and items for complex issues
• Perform additional duties as assigned.

What you will need:

• Bachelor’s degree in the area of Business, Training & Development, Education, Quality, or Human Resources related discipline.
• Experience supporting training processes for Pharma organization preferred.
• Experience with learning applications, integrated human resources applications or integrated document management applications is preferred.
• Experience creating/distributing metrics reports.
• Knowledge of training needs analysis, instructional/program design, development and evaluation, adult learning concepts and learning methodologies.
• Ability to influence management, business groups, and Subject Matter Expert (SME)’s toward a recommended thought or action.
• Good analytical and problem-solving skills.
• Ability to support various local projects and work well in a fast-paced environment.
• Proven customer service, organizational and team collaboration skills.

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.