Quality Manager (GxP), United Kingdom and Ireland

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO

• As part of the UK Regulatory and Quality Affairs team, the Quality Manager (GxP) will be responsible for managing the implementation and execution of the Enterprise Quality System at the UK affiliate (covering UK, Ireland and Malta). The candidate will be the primary Quality contact in their specific designated region/country and will have strong experience in GxP’s quality systems. The Quality Manager will be working independently and in a matrix environment.
• Act as Delegate/Deputy to the Responsible Person (RP) and Responsible Person (import) (RPi) named on the Alexion UK Wholesale Dealers Authorisation (WDA) and provide support in ensuring the provisions of the license are observed in accordance with the EU Guidelines on Good Distribution Practice of Medical Product for Human Use (2013/C 343/01) and Human Medicines Regulation 2012 and amendments.
• Support the Affiliate Regulatory and Quality Affairs leadership to drive the Quality Culture locally, in partnership with the county leadership through learning, embedding quality mindset, and sustainable continuous improvement.
• Support monitoring and the continuous improvement of the Affiliate Quality KPI/metrics.
• Support key process/system improvements in collaboration with Quality business partners (QBRs) and other Quality colleagues.

PRINCIPAL RESPONSIBILITIES

• In coordination with the Associate Director, Quality Country UK/Ireland, and related peers within the Enterprise Regulatory and Quality Affairs organization, the Quality Manager will work to ensure the roll out and on-going compliance to Alexion’s global quality and compliance systems, associated procedures and standards and local regulations.
• Provide support to Enterprise Regulatory and Quality Affairs and the designated Affiliate.
• Ensure that Alexion Policies, Enterprise Quality Standards Operating Procedures (SOPs) are implemented in accordance with US, EMA, other global and local GXP guidelines.
• Coordinate Self-inspections and internal auditing resource to assess site compliance on a regular basis. Perform self-inspections.
• Manage the review and implementation of Quality Improvement/remediation plans for the Affiliate identified through Enterprise as well as internal GxP audits.
• In collaboration with the Enterprise Quality organization, weigh and communicate quality and compliance risks as appropriate.
• Monitor GDP compliance to regulations and Alexion’s procedures and communicate CAPAs and action plans to Country Management and Enterprise Regulatory and Quality Affairs.
• Act as Quality liaison between the local operational groups and Enterprise Regulatory and Quality Affairs for GDP/GXP functions and activities.
• Partner with local, regional, and global operational groups to foster a proactive approach to compliance.
• Provide Quality Oversight for Homecare Providers (Patient Support Programmes) and vendors in UK/IE and guide the local teams to escalate to Enterprise quality when required.

RESPONSIBLE PERSON (RP) RESPONSIBILITIES:

Act as the delegate/deputy Responsible Person (RP) to the primary RP named on the Alexion UK licence and assist in ensuring the provisions of the licence are observed in accordance with the EU Guidelines on Good Distribution Practice of Medical Product for Human Use (2013/C 343/01), and local legislation as follows:

• a quality management system is implemented and maintained.
• Support in the management of authorized activities and the accuracy and quality of records.
• Ensure initial and continuous training programs are implemented and maintained.
• Support in the Coordination of any recall operations for medicinal products.
• Ensure relevant customer complaints are dealt with effectively.
• Ensure suppliers and customers are approved.
• Support the RP and Global Supplier Quality team in approval of any subcontracted activities which may impact on GDP.
• Ensure that self-inspections are performed at appropriate regular intervals following a prearranged.
• program and necessary corrective measures are put in place.
• Approve any returns to saleable stock.
• Ensure additional requirements imposed on certain products by national law are adhered to.

RESPONSIBLE PERSON IMPORT (RPI) SUPPORT RESPONSIBILITIES

Provide support and oversight for RPi activities in ensuring compliance with QP certification requirements have been met for products that have been imported into Great Britain (England, Wales and Scotland) from countries on an approved country of import list as defined by the MHRA.