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Senior Manager/Associate Director Global Quality Assurance Technology, EMEA
Endon United Kingdom,
Posted on : 19 June 2017
Senior Manager/Associate Director, Global Quality Assurance EMEA
Verified by HR:
Director, GQA - EMEA
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.
Influences: Directors and/or Managers of European manufacturing Site QA, Senior
Management and Technology Managers of Contract Manufacturing Management (CMM) in EU-TD, CTM-QA.
Purpose of the Position:
- To realise high quality consistency of products in both 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-QA and EU Region Affiliates communicating with GQA and other regional QA. European manufacturing sites (Plants) include manufacturing Meppel, CTM-QA, Kerry and Dublin plants.
- To develop relationships with other Astellas stakeholders (including GCRQA-EU, DSP/PV, Legal, Operations, Regulatory 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:
Associate Director GQAE
- Deputise for Director GQAE when he is absent.
- Proposition for the Pan-European documents to be developed and its preparation and training to the stakeholders. Review of implementation and maintenance of the Quality Systems of the Plants and Affiliates.
- Assessment of the consistency of the Quality System in the Plants and Affiliates by conducting internal audits.
- 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. Participate in regular meeting with GQA.
- Review the audit and inspection of plants by Health Authority, external consultant and GQA. Take part in special audit of the plants, contract manufacturers and affiliate operations.
- Secretariat and delegation of Executive Director QA Europe for European Regional REC (Risk Evaluation Committee) for Risk management of defective medicinal products and manage REC outcomes.
- Plan EMEA Region QA conferences and ensure deliverance of value adding agenda and management of meeting outcomes
- Coordinate and execution of training programs to QA members and responsible staff for cross functional quality processes.
- Inform and facilitate site QA Heads of new draft and/or definitive guideline in external Quality Assurance requirements, EMEA, ICH etc.
- Manage documentation handled in department.
- Review and approve Technical Agreements for European products.
- Review and monitor the progress of Technical Agreement for European products prepared by outside Astellas.
- Advice to GQA for the improvement of global QA systems and procedures.
- Regional and Local product quality review.
- Involvements of QA for cross functional IT system.
- Audit to the suppliers and Astellas affiliates.
Contribute to the Global QA Management and communicate with GQA
• 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 Associate Director must have the personal and intellectual standing to command the respect of European, American and Japanese colleagues and Authorities and Suppliers.
- Direct Reports – None
- Indirect Reports - None
- VPs, Directors and General Managers, Senior Managers. - Frequency – Monthly. Role – Review elevated Quality Assurance issues, identify the appropriate application of Regulations and recommend action. Represent APEL globally on QA issues.
- All APEL Managers, QA in Japan, US, European Regulatory Authorities, suppliers.
- Communication: Verbal – clear exposition of regulations and appropriate alternatives & recommendations. Written – reports and presentations.
Specific Environmental Factors:
• Travel-Mainly the UK, 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
- English speaking and writing.
- Common Sense approach to work.
- Analytical approach to problem solving.
- Ability to contribute to strategic planning.
- Eligibility for Qualified Person status.
- 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.
- Associate Director level (grade 12) must be QP qualified.
- Substancial relevant experience
- Quality Assurance and Quality Control experience as a pharmacist or equivalent qualification in European Pharmaceutical
- Manufacturing environment is essential. Eligibility for Qualified Person (GMP)
- Auditing experience.
- Knowledge of GMP and QA systems. Knowledge of European Directives related to Pharmaceutical Industry.
- Multi regional experience
Hillswood, United Kingdom
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