Facilities Compliance Manager

2 weeks ago

Dublin, Dublin City, Ireland beBeeLeadership Full time €100,000 - €123,456
Site Inspection Leadership

The Site Inspection Lead plays a pivotal role within our organization, responsible for ensuring GMP compliance and inspection readiness at the manufacturing site. This critical position requires strong leadership, accountability, and organizational skills, as well as the ability to negotiate and collaborate with stakeholders at all levels.

Key duties include:

  • Leading self-inspections to ensure GMP compliance
  • Conducting facility walk-throughs to identify areas for improvement
  • Managing the self-inspection program, including scheduling, CAPAs, and training
  • Supporting regulatory inspection readiness and participating in global audits
  • Auditing third-party suppliers to ensure compliance with policies and procedures

This role demands exceptional leadership and accountability skills, as well as the ability to read and interpret complex business and/or technical documents. The ideal candidate should also be able to write comprehensive reports and detailed business correspondence.

Required Skills and Qualifications:

  • Minimum of a primary or higher degree in Science, Engineering, or related field
  • 10+ years' experience in GXP environments, including Quality Assurance
  • Strong understanding of cGMP and global regulatory requirements (FDA, WHO, EMA, ICH, ISO 9001)
  • Proven leadership and accountability skills
  • Ability to read and interpret complex business and/or technical documents
  • Ability to write comprehensive reports and detailed business correspondence

Benefits:

Our organization offers competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to make an impact on the lives of others.

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