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Why you should apply:
* This is an excellent opportunity and is a high impact role where you will lead a diverse team of quality professionals that are responsible for quality operations for the site, including batch release, sterility and compliance.
* Generous Salary & Benefits package, as well as career development opportunities
What you will be doing:
* Provide leadership and oversight to ensure sterile products filled meet requirements of end users, Regulatory Authorities and the company.
* Direct the quality team to ensure that products manufactured are manufactured in accordance with the relevant GMPs.
* Develop and deliver strategic improvements to the quality system to ensure effective manufacture of products including providing leadership and direction on the pipeline of NPIs.
* Develop a strong proactive Quality team to ensure all products (commercial and NPI (CTS)) produced are manufactured in compliance with the applicable GMPs and Quality Systems.
* Develop and lead the site QP team to compliantly manage batch release and ensure excellent product performance for all processes and maintain compliance with appropriate commercial and clinical regulatory filings.
* Develop processes and procedures to assure aseptic products manufactured to meet requirements of end users, Regulatory Authorities and of the company.
* Ensure manufacture has been carried out in accordance with all applicable Good Manufacturing Practice, e.g., EU GMP Annex 1 and FDA regulations.
* Ensure all the necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes.
* Ensure all necessary production and quality control documentation has been completed and endorsed by the staff authorised to do so.
* Advance the knowledge and experience of the QA ops team and Operations teams to ensure they are minimally up to date in terms of technical and scientific advancements and changes in quality expectations relevant to the products they are required to manufacture and certify.
* Liaising with global Quality Assurance and Regulatory groups, FDA, HPRA and other Regulatory bodies (where applicable).
* Liaising with Product Quality, S&T and Regulatory affairs function in relation to product filing support
* Develop proactive relationships with R&D and other global teams to ensure effective transfer of NPIs to site and its progress into clinical / commercial manufacturing
* Working with QA Director, Quality Control and Quality Systems group to ensure site meets its customer, quality service, regulatory and financial goals.
What you need to apply:
* Degree level qualification in a science discipline with minimum 6 years experience in the healthcare/pharmaceutical industry.
* MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive /83/EC is preferred Minimum 2+ years of supervisory and managerial experience in a Manufacturing related area in a Biotechnology, Pharmaceutical or medical device organisation
* Minimum 2 years+ experience in manufacturing processes of drug product/substance, including aseptic filling, visual inspection of drug product, solutions preparation, and sterilization operations preferable.
* Experience and proven track record in audit management and regulatory interaction management.
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