THIS IS WHAT YOU WILL DO:

• Responsible for delivery of quality assurance activities at Alexion’s Irish locations to ensure commercial and/or clinical products are manufactured in accordance with cGMP, Corporate and Regulatory requirements. This responsibility requires the delivery of QA and compliance support for the Irish site(s).
• The Senior Manager QA executes the site QA activities at Alexion in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Operations, QC, Site Services, Engineering and Planning to optimize patient supply.
• This role is responsible for the quality oversight of new product introductions onto the Athlone site from initial manufacturing through to clinical and commercial supply and on-site quality systems management including deviations, change controls, supplier management, complaints, recall management & QRM.

YOU WILL BE RESPONSIBLE FOR:

• Site QA responsibility to provide oversight and technical expertise for all QA and compliance topics/issues relating to Alexion manufacturing and product supply. Ensures the timely QP release of commercial and clinical product in accordance with agreed timelines for Drug Substance and Drug Product.
• Works closely and communicates regularly cross site(s) with finished product release QPs
• Acts as quality point person, providing feedback on quality systems to the Global Operations Quality group
• Provides quality oversight and ensures documents are approved to schedule to support technology (external and internal) transfers and new product introductions.
• Retain, lead, coach and develop QA Specialists. Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
• Act as designee for the Department Manager in their absence.
• Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk
• Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Clinical and Commercial Operations groups.
• Provide sound QA and Compliance support to manufacturing, engineering, utilities, supply chain and material movement (including cold chain) for both clinical and commercial products.
• Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
• Deliver Quality Assurance review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports as required.
• Actively contributes to continuous improvement activities.