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Senior Manager QAE - United Kingdom  

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Posted on : 10 July 2017

Project Description

Job Title:

Senior Manager, Quality Assurance

EMEA

Job Family:

 

Department:

GQAE

Grade:

11

Verified by HR:

SR

Date:

July 2014

Competency:

Manager

 

Organisational Fit:

Reports to:

Director, GQA – EMEA - Neil Churcher

Peers:

Managers and (associate) Directors in APEL, GQA, QA of APUS and Regulatory Affairs in APEB and Affiliates, Pharmacovigilance department in R&D, Crisis Team Leader in APEL,Legal Department in APEL

Subordinates:

Direct: None

Influences: Directors and/or Managers of European manufacturing Site QA, Technology Managers  in EUTD, CTM-QA

 

Purpose of the Position:

 

  • To realise high quality consistency of products in both the development and commercial stages and contribute to QA support for commercial readiness activity
  • To monitor the quality risk for Quality Assurance of European marketed products in terms of GMP and GDP and to lead and supervise Quality Assurance of such Products including Development Products, based on Quality Systems of the sites and departments.
  • Products include Active Pharmaceutical Ingredients, Investigational Medicinal Products and Authorized Medicinal Products.
  • To coordinate and cooperate Quality Assurance Activities with European manufacturing sites, CMM and Affiliates communicating with GQA and other regions.
  • European manufacturing sites (Plants) include manufacturing Meppel, CTM Leiden, Kerry and Dublin plants.
  • To develop relationships with other Astellas stakeholders (including GCRQA-EU, DSP Legal, Operations,Regulatory, Medical Pharmacovigilance and Affiliates).
  • To collect new developments in external Quality Assurance requirements, EMEA, ICH etc. and give the training to relevant departments.

 

Core Tasks, Responsibilities and Authority:

Senior Manager GQAE

  • Proposition for the Pan-European documents to be developed and its preparation and training to the stakeholders. Manage documentation handled in department.
  • Assist in preparation of the Global Audit Plan and monitoring of the plan in the EU region.
  • Surveillance of Significant Quality Issues (SQIs) and resultant investigations in the EU Region.
  • Ensuring IT systems are in compliance with Regulatory and Corporate GxP requirements.
  • Review of implementation and maintenance of the Quality Systems of the Marketing Affiliates.
  • Assessment of the consistency of the Quality System in the Plants.
  • Monitoring and periodical review of Customer Complaints on behalf of Astellas European Organization
  • Monitoring and periodical review of pan European Quality Systems and participation in Management Review activities..
  • To act for liaison with RAE, R&D and external bodies (European Health Inspectorates) to represent APEL on QA/QC issues and maintaining QA/QC requirements for standards within Production.
  • Advise European plants and affiliates about the quality system to comply with QA requirements.
  • Secretariat and Assist in organising Regional QA Meeting.
  • Review the audit and inspection of plants by Health Authority, external consultant and API Corporate QA. Take part in special audit of the plants and contract manufacturer.
  • Operate cross functional aspects of change control process and integration in Quality System.
  • Coordinate and execution of training programs to QA members
  • Inform and facilitate site QAs of new draft and/or definitive guideline in external Quality Assurance

requirements, EMEA, ICH etc.

  • Secretariat and delegation of Executive Director GQAE for European Regional REC (Risk Evaluation Committee) for Risk management of defective medicinal products.
  • Assist in preparing Technical Agreements for European products.
  • Support the Regional and Local product quality review.
  • Audit to the suppliers and Astellas affiliates.

Contribute to the Global QA Management and communicate with GQA

  • Assist the review of the Astellas QA Manual/SOP and consolidation of the review by the site.
  • Prepare monthly report to GQA and EUTD.

Scope of Job

  • The Quality Assurance Senior Manager must have the personal and intellectual standing to command the respect of European, American and Japanese colleagues and Authorities and Suppliers.

 

Quantitative Dimensions:

Direct Reports- none

• Indirect Reports None

 

Interpersonal Relationships:

  • Level – VPs, Directors and General Managers, Senior Managers, and Managers.
  • Frequency – Monthly.
  • Role – Listen to quality assurance issues, identify the appropriate application of Regulations and recommend action. Represent APEL globally on QA issues.
  • Int/Ext – All APEL Managers, QA in Japan, US, European Regulatory Authorities, suppliers.
  • Communication:  Verbal – clear exposition of regulations and appropriate alternatives and recommendations.  Written – reports and presentations
 

 

Specific Environmental Factors:

  • This position can be based in The Netherlands or UK.
  • Travel - Mainly to The Netherlands, also Ireland and other European Countries and some visits to

Japan and US.

  • Availability-Continuous availability, also outside business hours, to respond to serious pharmaceutical technical complaints on behalf of Executive Director Quality Assurance Europe

 

Professional Profile

Competencies

Experience

  • English speaking and writing.
  • A working knowledge of Dutch and/or Irish

would be very useful.

  • Common Sense approach to work.
  • Analytical approach to problem solving.
  • Ability to contribute to strategic planning.
  • Knowledge to complete Eligibility of Qualified Person is desirable.
  • Good communication skills, both written and spoken, are necessary.
  • Awareness of Corporate politics and able to manage with sensitivity key stakeholders from diverse cultural and professional backgrounds.
  • Good relevant experience
  • Quality Assurance and Quality Control

experience as a pharmacist or equivalent qualification in European Pharmaceutical

Manufacturing environment is essential.

  • Knowledge to complete Eligibility of Qualified Person is desirable.
  • Knowledge of IT systems compliance to GxP
  • Auditing experience.
  • Knowledge of GMP and QA systems
  • Knowledge of European Directives related to Pharmaceutical Industry.
  • Regional experience.