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Astellas Career Portal

Manager QAE

Publication date: 13-09-2017 Job category: Quality Assurance & Quality Control
Location: Hillswood Education level: Bachelor/Graduate
Country: United Kingdom Level: Professional
Employment: Fulltime

Astellas Global Quality Assurance is recruiting for a QA Manager to  support QAE Senior Managers and Directors in the assurance of high quality consistency of development and commercial products and ingredients for EMEA region.

Fulltime

Permanent

Office based – Chertsey, Surrey, with some International travel

Salary - Competitive salary and benefits

Opening Date -  24th July 2017

Closing Date for Applications - 4th September 2017

 

Your role as QA Manager is to develop effective relationships with QAA and QAJAO colleagues and other Astellas stakeholders (including CRQA, PV, Legal, Operations, Regulatory, Medical, Affiliates and Technology functions) in order to support QAE Senior Managers and Directors in the assurance of high quality consistency of development and commercial products and ingredients for EMEA region.

 

Key Responsibilities

Compliance:

  • Embed Compliance Culture across all Regions of the business ensuring Integrity in Action is actively, applied in all initiatives.
  • Ensure Quality Assurance Function(s) strictly adopt a culture of ethics and compliance; leading by example and appropriately challenging non-compliance.   
  • Ensure adherence to Astellas policies relating to Ethics and Compliance standards and interactions with Healthcare Professionals (HCPs), Healthcare Organisations (HCOs) and Patient Organisations (POs).

     

    Quality Assurance Activities:

  • To support Senior Managers and Directors in the operation and continuous improvement of GMP and GDP Quality Systems of the manufacturing sites and departments in EMEA region.
  • Provide data collection and trend reports from such systems to identify areas of focus and attention.
  • To assist in coordination of Quality Assurance Activities with European manufacturing sites (Meppel, CTM Leiden, Kerry and Dublin plants), CMM and Affiliates.
  • To assist in the support of European manufacturing sites and CMM in overseas inspections from emerging market Health Authorities e.g. Russian, Belarus etc.
  • To assist in supporting the affiliate Sub-Regional Leads in QA activities where required, in particular those affiliates based in emerging markets.
  • Participate and contribute to EMEA regional meetings and conferences and resulting actions
  • Prepare metric data related to QAE to support management review process.
  • Assist in planning, conducting and reporting of GxP audits in EMEA region.
  • Maintain a working knowledge of latest regional and global regulations pertinent to EMEA operations including emerging market regulations.
  • Where requested, participate in global/regional projects related to global/regional QA activity.
  • Other such duties as may be reasonably required by the business.

 

Skills & Experience

Required

  • Pharma sector experience with strong customer focus; in multi-disciplinary, matrix and cross-cultural settings.

 

  • Comprehensive understanding and proven track record operating within QA in a manufacturing and/or affiliate environment
  • Proven experience operating within Global QA projects to include cross-border working, regulatory authorities knowledge in country/region and variances to navigate to appropriate solutions etc.
  • Extensive track-record of leading QA planning process with excellent organisational and collaboration skills in progressively more complex and virtual teams
  • Experience of liaising and collaborating closely with PV, Regulatory Affairs, Medical Affairs and Health Authorities (HA’s) in a compliance and robust manner.
  • Excellent communication skills to work with diverse teams both locally and virtually, and ability to demonstrate sensitivity to cultural differences
  • Sensitivity to interact with emerging markets and various levels of ‘maturity’ in QA model in order to help them harmonise, knowledge share and ultimately implement best practice techniques in QA.
  • Proven compliance expertise; to understand and comply with industry laws and relevant regulations including emerging market legislation i.e. Russia, Turkey, Middle East etc.
  • Coaching and collaboration skills to interact across cultures - and at various levels of management and personnel - to achieve shared goals.
  • Demonstrable examples of ability to share expertise and coach teams to promote knowledge sharing.
  • Proven ability to influence, and appropriately challenge and engage diverse senior stakeholders. 
  • Fluent in written and verbal business English and a second language from EMEA region.  Distinct advantage if a language from emerging markets e.g. Russian, Turkish, Arabic etc. (emerging markets languages).
  • Graduate or equivalent professional qualification and/or proven expertise (including willingness to work towards Qualified Person status and develop further within QAE specialisms).

 

We offer

·         A challenging and diversified job in an international setting

·         Good career opportunities

·         Inspiring work climate

·         Attractive remuneration package

 

 

Location:


Hillswood

Contact

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