Biopharmaceutical Company focused on improving patients' lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs. They are currently looking for a Quality Director to work on their small molecule product portfolio.
The company has a portfolio of medicines through its orphan, primary care and rheumatology business units. The companies global headquarters are in Dublin, Ireland. The company also has office locations in the US and Europe. This role would manage product portfolio for the company's small molecule products. The CMO's are predominantly based in Europe and some in the US. The QA team of 12 is growing and they manager a broad range of dosage forms. The successful candidate will work in close partnership with the whole Tech Op's function.
- Reporting directly to the Senior Director of Quality Operations, the Director is part of the quality team responsible for the quality operational activities for all Horizon commercial products. The team is responsible for ensuring the highest quality standards for the product portfolios by managing the operational quality system elements of deviations, CAPAs, change controls and product complaints.
- Leading and monitoring the daily operations at Contract Manufacturer(s), responsible for oversight of batch review and disposition, reviewing and approving product complaints, deviations, change controls.
- Leading product related investigations and supporting product quality related priorities and tasks at the respective contract manufacturers, distributors and/or suppliers.
- Building authentic relationships and leading business meetings and audits of critical suppliers and contract manufacturers and maintaining all product related Technical Quality Agreements (TQAs).
- Ensure compliance of all respective contract manufacturers/suppliers to both internal company requirements and country specific regulations.
- Oversight of all product testing, methods, and investigations, including monitoring, tracking and reporting Quality KPIs.
- Evaluate proposed changes to the manufacturing and supply chain processes, including conducting regulatory impact assessments, and authorize these changes, if appropriate.
- Highlight any risks associated with maintaining supply of commercial drug products to all markets and offer innovative and effective ways to minimise such risks.
- Leading external audits and assisting in internal audits and regulatory agency inspections as needed.
- Designing, implementing and improving quality systems to realise the highest quality standards attainable for all activities conducted by the company, supporting Product Quality Review and annual report completion on time.
- A Master's degree in a science discipline is required, with an excellent understanding of quality assurance and CMC regulatory requirements.
- 10+ years pharmaceutical experience in Quality Control and/or Quality Assurance.
- Qualified Person status is desirable.
- A strong understanding of, and experience in quality management is essential.
- Knowledge of QA for all pharmaceutical dosage forms and drug substance manufacture is desirable.
Competitive salary, healthcare, pension and bonus.
This is an organisation that is driven my innovation, collaboration and people who are passionate about they do.
For immediate consideration please apply with an up to date CV. Not sure yet no CV ready? Please get it touch for more information.
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