QA Site Inspection Manager - 12 Month Assignment

Location:  Cork, Ireland Category: Quality

Hiring Manager: Eilis O'Callaghan ([email protected])

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Description

Who We Are

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.

QA Site Inspection Manager - 12 Month Assignment 
Closing date for applicants- 24th May 2024
QA Systems
BioMarin International Ltd., Shanbally
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
 
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.
 
Essential Job Functions:
 
  • 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.


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.

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