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alexion

Associate Director, UK & Ireland Country Quality / RP and RPi for UK

Location: London, United Kingdom Job reference: R-195130 Date posted: 06/05/2024

This is what you will do:

The Associate Director, UK & IE Country Quality, will be responsible for providing operational quality support to commercial and GxP teams in the distribution of Alexion products. This individual ensures effective communication and  working relationships with all functional company groups as well as with external stakeholders and regulatory authorities concerning GDP/GMP.

The Associate Director oversees the implementation, management  and execution of the Enterprise Quality System at the UK affiliate and has  strong experience in GxP’s quality systems.  The Associate Director is expected to be able to work  independently and in a matrix environment.

The Associate Director, UK & IE Country Quality will act as the Responsible Person (RP) and Responsible Person (import) named on the Alexion UK Wholesale Dealers Authorisation (WDA) and ensures that 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 Human Medicines Regulation 2012 and amendments.

You will be responsible for:

  • In coordination with the Director, UK &Ireland Regulatory Affairs and Quality, other Managers, Quality Assurance and related peers within the Enterprise Quality organization, the Associate Director 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 leadership and resource management support to Enterprise Regulatory and Quality Affairs and affiliate Quality guidance. 
  • Ensure that Alexion Policies, Enterprise Quality Standards Operating Procedures (SOPs) are implemented in accordance with US, EMA, other global and local guidelines
  • Coordinate GDP Self-inspections and internal auditing resource to assess site compliance on a regular basis. Perform self-inspections
  • Ensure Alexion, local and global, is kept fully informed of new or emerging  GMP/GDP regulatory changes in their region
  • 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 GDPcompliance to regulations and Alexion’s procedures and communicate CAPAs and action plans to Country Management and Enterprise Quality
  • Act as Quality liaison between the local operational groups and Enterprise Quality 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.
  • Act as the primary Responsible Person (RP) named on the Alexion UK licence and ensure that 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:
    • Ensure a quality management system is implemented and maintained;
    • Focus on the management of authorised activities and the accuracy and quality of records;
    • Ensure initial and continuous training programs are implemented and maintained;
    • Coordinate and promptly perform any recall operations for medicinal products;
    • Ensure relevant customer complaints are dealt with effectively;
    • Ensure suppliers and customers are approved;
    • Approve 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;
    • Keep appropriate records of any delegated duties;
    • Support the outsourced provider, when required, on the final disposition of returned, rejected products;
    • Approve any returns to saleable stock;
    • Liaise with the local Health Authorities as required on the notification and final disposition of recalled and falsified products.
    • Ensure additional requirements imposed on certain products by national law are adhered to;
    • The Responsible Person should fulfil their responsibilities personally and should be continuously contactable. The Responsible Person may delegate duties but not responsibilities.
  • Responsible Person Import (RPi) Responsibilities
    • Responsible for implementing a system to confirm that the required QP certification has taken place 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. The RPi may delegate the activity of checking QP certification has taken place but remains responsible for ensuring the effectiveness of these checks.

You will need to have:

  • 8 years+ of hands-on Quality Assurance/ Compliance and management experience in pharmaceutical/ biotech industry.
  • Bachelor's Degree in physical /life science or pharmacy.
  • Eligible to act as Responsible Person named on the UK Wholesale Dealers Authorisation (WDA)
  • A member of a professional body with a published code of conduct as defined by the MHRA or as is equivalent to qualify as a Responsible Person (import)
  • Thorough knowledge of applicable local and global regulatory requirements required for GDP
  • Good knowledge of government regulations, laws and guidelines (local MHRA regulations, EMA) pertaining to GDP required
  • Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.
  • Strong leadership ability
  • Exceptional communication and interpersonal skills
  • Ability to work globally in a matrix environment
  • Ability to influence senior management, peers and other colleagues without direct reporting lines
  • Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
  • Ability to multi-task and prioritize work
  • Strong organizational ability
  • Experience in using computerized system for Change Control, Deviation and CAPA management.

We would prefer for you to have:

  • Good knowledge of government regulations, laws and guidelines (local MHRA regulations, EMA) pertaining to GMP and GVP.
  • Advanced degree in physical /life science or pharmacy.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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