Director of Commercial Quality
This international company focuses on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. Since their founding they have focused on putting the patient first and this remains their priority as they continue to develop, acquire and commercialize new treatment options for patients with challenging conditions that no one else is tackling. Currently employing over 1000 staff globally with offices in the U.S. and Europe. They are a continually growing company with a broad portfolio and a very healthy pipeline. Due to continued expansion, this organisation are now looking to appoint a permanent Director of Commerical Quality to their growing team.
- Managing product quality related priorities and tasks at the respective contract manufacturers
- Leading and monitoring the daily operations at the Contract Manufacturer, performing batch review and disposition, reviewing and approving product complaints, deviations, change controls and leading product related investigations
- Lead and manage a QA team, including setting goals, performance review, training, development and budgeting
- Designing, Implementing and improving quality systems to realize the highest quality standards attainable for all activities conducted by the company, supporting Product Quality Review and annual report completion on time and leading training
- Facilitating technology transfer, process scale-up and process improvement protects
- Building authentic relationships and leading business meetings and audits of critical suppliers and contract manufacturers and maintaining all product related Quality Technical Agreements (QTAs)
- Leading and assisting in internal audits and regulatory agency inspections
- Collaborate with all contract manufacturers, packagers and testing laboratories to resolve any quality issues and guarantee an uninterrupted supply of drug product to the markets.
- Participate in due diligence activities associated with strategic partnerships or new company acquisitions
- Contribute to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers, packagers and laboratories, as required.
- Maintain quality and regulatory compliance, to ensure that there are no significant regulatory agency citations associated with any company specific GMP activities. In this respect, it may be necessary to collaborate with the regulatory affairs department and liaise with regulatory agencies in the process of resolving GMP specific quality issues.
- Evaluate proposed changes to the manufacturing and supply chain processes, and authorize these changes, if appropriate.
- Contribute to management of the supplier approval programme and to maintenance of the external audit schedule.
- Understand new regulations and guidelines, as they apply to the company business, and implement systems and procedures to incorporate these new regulations, if appropriate.
- Ensure compliance of all respective contract manufacturers to both internal requirements and country specific regulations
- Highlight any risks associated with maintaining supply of commercial drug products to all markets and offer innovative and effective ways to minimize such risks.
- A Masters or PhD level in a science discipline is required, with an excellent understanding of quality assurance. Qualified person status and experience is required. A strong understanding of, and experience in quality management is essential with a proven track record in people management and personnel development.
- At least 10 years’ experience gained in finished product pharmaceutical manufacturing is required.
- Knowledge of QA for all pharmaceutical dosage forms, biotechnology products and drug substance manufacture is desirable. An excellent understanding of quality guidelines and regulatory requirements as they apply to the industry is required.
To learn more apply on line or call Shane Browne on +353 1 6321865.
Salary: On Application
Location: Dublin City Centre