Senior Quality Lead

2 weeks ago

Dublin, Dublin City, Ireland beBeeQuality Full time €60,000 - €70,000
Senior Quality Lead

We are seeking an experienced Senior Quality Lead to join our team in Ireland. This is an exciting opportunity to make a meaningful impact by ensuring the highest standards of quality and compliance in pharmaceutical manufacturing.

The role involves EU batch certification and release, as well as ensuring compliance with GMP aspects of laws governing product importation into the EU.

About the Role

This is a senior-level position that requires a high level of expertise in quality management, GMP regulations, and pharmaceutical manufacturing. The successful candidate will be responsible for ensuring a compliant operation is in place to allow QP certification of batches of pharmaceutical products.

The ideal candidate will have significant experience in pharmaceutical manufacturing and quality operations, as well as knowledge of GDP regulations.

  • Ensure a compliant operation is in place to allow QP certification of batches of pharmaceutical products.
  • QP certify all batches of Pharma products imported into EU in accordance with requirements of EU Guidance on GMP Part1, Annex 16 and Annex 21.
  • Ensure the QP Importation operation is inspection ready and lead/host regulatory inspections of the QP certification process.
  • Ensure oversight of supply site operations via formal quality meetings with the site, involvement with internal audits undertaken at the sites and visits to view operations as required.
  • Support regulatory inspections of supply sites, as required.
  • Perform audits of the importation supply chain to ensure compliance with GMP, GDP and MIA authorisation, as required.
  • Actively represent QP Importation on assigned projects, as required.
  • Mentor and coach junior members of the team.
Requirements

To be considered for this role, you will need:

  • A scientific degree.
  • Significant experience in pharmaceutical manufacturing and quality operations.
  • Experience with the certification of major dose forms (tablets, cream/ointments), aseptic sterile manufacture and biopharm products.
  • Experience in management of Manufacturer Importation licences.
  • Knowledge of GDP regulations.
Benefits

We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programs, pension plan membership, and shares and savings program.

We also offer a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

About Us

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance.

We have a global network of 37 medicines and vaccines manufacturing sites, delivering 1.7 billion packs of medicines and 409 million vaccine doses in 2024.

We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.

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