Chief Quality Assurance Director

1 day ago

Dublin, Dublin City, Ireland beBeeQuality Full time €60,000 - €90,000
Lead Quality Assurance Manager

The Lead Quality Assurance Manager will be responsible for the development, implementation, and ongoing maintenance of the Quality Management System. This role is pivotal in maintaining full compliance with Good Distribution Practice, Good Manufacturing Practice, and applicable regulatory requirements.

Key Responsibilities:
  • Responsible Person & Regulatory Compliance Oversight: Ensure the organisation meets all obligations under its Wholesale Distribution Authorisation.
  • Quality Management System Leadership: Lead the development, implementation, and continuous improvement of the Quality Management System.
  • Pharmacovigilance & Regulatory Affairs Management: Oversee Pharmacovigilance operations ensuring compliance with global safety reporting obligations.
  • Cross-functional Collaboration & Team Leadership: Foster collaboration with Supply Chain, Commercial, and Regulatory Affairs functions.

The successful candidate will have three to five years of experience in a regulated pharmaceutical environment, with proven expertise in Pharmacovigilance operations, Regulatory Affairs, and distribution compliance. Prior experience as a Responsible Person under a Wholesale Distribution Authorisation is essential. A strong understanding of Good Distribution Practice and Marketing Authorisation Holder responsibilities is required, along with experience managing safety data, regulatory submissions, and promotional compliance.

Required Skills and Qualifications:

  • Proven track record of implementing and maintaining Quality Management Systems.
  • Strong knowledge of Good Distribution Practice and Marketing Authorisation Holder responsibilities.
  • Experience managing safety data, regulatory submissions, and promotional compliance.
  • Excellent leadership and team management skills.

Benefits:

  • Opportunity to work with a leading organisation in the pharmaceutical and healthcare services sector.
  • Competitive salary and benefits package.

Others:

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