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Position Overview:

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Our client are seeking an experienced and seasoned QA professional in Ireland to join their flagship Biologics manufacturing facility as Quality Assurance Operations Manager. This is a crucial role where you will be responsible for leading and oversight of the production of sterile products, ensuring compliance with regulatory standards and company requirements. You will also be responsible for building and managing the quality team to adhere to GMPs and implement strategic improvements to the quality system for both commercial and new products.

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Key Responsibilities:

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• Ensure aseptic products meet user, regulatory, and company standards.

• Oversee manufacturing compliance with EU GMP Annex 1 and FDA regulations.

• Perform necessary checks, tests, and documentation for quality control.

• Keep QA and Operations teams updated on technical and scientific advancements.

• Collaborate with global Quality Assurance, Regulatory groups, and R&D teams.

• Work with QA Director and Quality Control to achieve customer, quality, regulatory, and financial goals.

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Qualifications:

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• Degree in a science discipline with 7+ years in biopharmaceutical/pharmaceutical industry.

• Preferred: MSc in Industrial Pharmaceutical Science for Qualified Person (QP) status.

• 3+ years supervisory/managerial experience in Manufacturing within Biotechnology, Pharmaceutical, or medical device sectors.

• Experience in drug product manufacturing processes, including aseptic filling and sterilisation operations.

• Proven track record in audit and regulatory interaction management.