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Manager/Senior Manager QAE - United Kingdom  

Astellas (company)


Posted on : 25 April 2017

Project Description

Purpose of the Position:           
  • To realize 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, Investigation Medicinal Products and Authorized Medicinal Products.  
  • To coordinate and cooperate Quality Assurance Activities with European manufacturing sites, CMM and Affiliates communicating with QA and other regions.  
  • European manufacturing sites (Plants) include manufacturing Meppel, CTM Leiden, Kerry and Dublin plants.
  •   To develop relationships with other  stakeholders (including CRQA-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 QAE     
  • 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  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 QAE 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  affiliates.     

Contribute to the  QA Management and communicate with QA     
Assist the review of the QA Manual/SOP and consolidation of the review by the site.  Prepare monthly report to QA 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.  Other such duties as may be reasonably required by the business.           

Mandatory Compliance Requirements: Induction    
  • To be aware of Group Code of Conduct and associated policies and procedures and other applicable laws, codes and regulations: to include the ABPI (The Association of the British Pharmaceutical Industry) and EFPIA (European Federation of Pharmaceutical Industries and Associates) Codes of Practice.        
  •   Clarify and seek guidance as required, and raise any concerns, in a timely manner, with relevant manager; which may include reference to the Ethics & Compliance Team and/or Ethics and Compliance Helpdesk.         
  • Undertake and comply with relevant mandatory Ethics & Compliance training and updates to maintain personal awareness; all training to be undertaken in a timely manner.         
  • Be aware of and comply with the company Way and Competences, in terms of expected values and behaviors, in addition to  HR policies, procedures and guidelines    

Quantitative Dimensions:     
Regional role - EMEA region  Influences Directors & Managers in other functions (e.g. M&D, Manufacturing Plants, CMOs, IS etc)  Direct Reports – None  Indirect Reports – None  Budgetary Responsibility - 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:     
  • 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     
  • Good organizational, coordination,  diplomatic, negotiation, presentation and communications skills. 
  • Earns the respect of other regional QA teams and stakeholders
  • Contributing to global impact projects and/or previous experience leading small QA teams  English speaking and writing. 
  • Common Sense approach to work.  Analytical approach to problem solving.
  •   Ability to contribute to strategic planning. 
  • 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. 
  • Science based degree (Pharmacy preferred). 
  • Relevant external pharmaceutical training.  Understanding of regional GxP requirements and directives. 
  • Appropriate knowledge of product type. 
  •  Knowledge acquired typically through at least 5 years in manufacturing GMP pharma roles and/or regional QA role  GxP audit experience. 
  • Knowledge of IT systems compliance to GxP  GxP Auditing experience.