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Operations Compliance Specialist

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BioMarin Pharmaceutical

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Location:
Ireland , Cork

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Reporting to the Inspection Readiness Lead, the Operations Compliance Specialist is responsible for all aspects of Documentation Management & Compliance including but not limited to the following main areas of responsibility of this role, which are as follows: Document Management; Compliance Tasks; Additional tasks.

Job Responsibility:

  • Manage the authoring & drafting of all types of Manufacturing Operations documentation
  • Specifications & associated forms in conjunction with the various departmental subject matter experts (SME)
  • Support document updates and manage timelines for cross functional Projects
  • Act as a SME/Superuser on the Controlled Document System to facilitate the processing & approval of documents
  • Organise & Facilitate Document Round Table meetings with cross functional teams as required
  • Mange and build Quality Veeva QMS metrics for Manufacturing Operations
  • Coach & Train colleagues in Documentation System & GDP queries
  • Support manufacturing operations on meeting deadlines on Veeva QMS records
  • Update compliance procedures and processes
  • Generate Reports/Metrics & analyze trends as required including but not limited to: Veeva QMS reports, Doc Tracker Lookaheads, ASI/AIC metrics, Logbook Metrics, Doc Tracker Metrics, RFT Metrics
  • Perform Logbook Training, review, and trending of all closed logbooks, identifying issues and managing timely archiving
  • Train and perform Area Self Inspections & Generate ASI schedule
  • Train Manufacturing colleagues in GDP/GMP
  • Management of Veeva paper Binders
  • Continuous monitoring of Compliance in Manufacturing
  • Facilitate all internal and external Inspections
  • Participate in permanent inspection readiness by completing Inspection walkthroughs within manufacturing operations
  • Collaborating with Global colleagues (as required) including but not limited to: Supplier Change Notifications, EDMS & Managerial Data Management
  • Management of Job Descriptions & New Hire Checklist and Assigning Lockers
  • Be proactive & collaborative in troubleshooting & resolving issues with documentation, training & systems collaborating with different departments across the site
  • Engage in Continuous Improvement Initiatives
  • Manage compliance projects and Inspection readiness updates
  • Apply aligned Operations Compliance Specialist role skills across Drug Substance, Drug Product and Packaging

Requirements:

  • 2+ years’ experience in technical writing and compliance
  • Proficient in data analytics, data visualization
  • Working knowledge in Regulations, GMP, GDP
  • 2+ working within a regulated healthcare industry including a role in capacity of quality and compliance
  • Strong verbal, written and oral communication skills
  • Able to work independently and be flexible to changing priorities

Additional Information:

Job Posted:
December 26, 2025

Work Type:
Hybrid work
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