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QA Site Inspection Manager

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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:

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. Come join our team and make a meaningful impact on patients’ lives.

Job Responsibility:

  • Develop strategy for and lead Permanent Inspection Readiness activities onsite
  • Foster a culture of permanent inspection readiness
  • Oversee trending of key audit / inspection performance metrics
  • Report and escalate issues to management
  • Define the BIL self-inspection program for site
  • Work with PIR team to implement the annual program
  • Benchmark leading practices & identify opportunities to enhance PIR capabilities
  • Provide guidance & direction to stakeholders on trends in recent regulatory inspections
  • Liaise with local and global colleagues to share learnings to ensure consistency across the network and alignment with global processes
  • Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures in conjunction with the accountable parties
  • Maintain the commercial site license, working closely with regulatory colleagues to address license impacting changes
  • Support site Quality Systems and escalate any potential issues / trends
  • Support facilitation of site quality management review and report generation
  • Other duties as assigned

Requirements:

  • 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 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

Additional Information:

Job Posted:
January 09, 2026

Expiration:
January 16, 2026

Work Type:
Hybrid work
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