Senior Quality Assurance Lead

2 weeks ago

Dublin, Dublin City, Ireland beBeeQuality Full time €98,100 - €118,900

Job Description:

We are seeking an experienced Quality Director to lead our team in ensuring the highest standards of quality assurance across all product-related activities.

The successful candidate will be responsible for developing and implementing a Quality Management System, ensuring full compliance with Good Distribution Practice, Good Manufacturing Practice, and applicable regulatory requirements.

This role is pivotal in maintaining our Wholesale Distribution Authorisation and ensuring adherence to obligations as a Marketing Authorisation Holder.

The Quality Director will oversee Pharmacovigilance activities, Regulatory Affairs, and Advertising compliance, ensuring robust systems and processes are in place to manage safety data, regulatory submissions, and promotional material reviews.

Key Responsibilities:

  • Serve as the designated Responsible Person, ensuring compliance with Good Distribution Practice, Good Manufacturing Practice, Medical Device regulations, and Marketing Authorisation Holder responsibilities.
  • Lead the development, implementation, and continuous improvement of the Quality Management System, including quality agreements, audits, deviation management, corrective and preventive actions, change control, and inspection readiness.
  • Oversee Pharmacovigilance operations ensuring compliance with global safety reporting obligations; manage Regulatory Affairs activities including product licensing, variations, labelling, submissions, and promotional compliance aligned with regulatory expectations.
  • Lead and develop the Quality team, foster collaboration with Supply Chain, Commercial, and Regulatory Affairs functions, manage external partners/vendors, and act as subject matter expert on Exempt Medicinal Products, driving process improvements and operational excellence.

Requirements:

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.

A Bachelor's degree in a scientific or healthcare discipline is preferred.

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