Senior Manager, Regional Quality Systems

Highly Competitive
  1. Permanent
  2. Good Distribution Practice (GDP)
  3. United Kingdom
Hatfield, England
Posting date: 24 May 2021

An exciting opportunity has arisen for a Senior Manager, Regional Quality Systems in the UK. In this role you will be Accountable for ensuring that operations carried out within the EML Quality System and EMEA Regional Quality System section are completed in accordance with the requirements of the company's Quality Systems, GMP Guidelines, GDP Guidelines and Industry Standards.

Job Responsibilities

  • To ensure that all Quality Systems are adequately resourced and managed.
  • To ensure all Quality Systems procedures meet Eisai corporate, pharmaceutical industry, GMP and GDP expectations:
  • Accountable for management of the following QMS process:
  • Product Quality Review
  • Supplier Management of GMP and GDP materials suppliers.
  • EML Training System supporting EML personnel and EMEA personnel for GMP/GDP requirements
  • Documentation management of Standard Operating Procedures for EML and the Regional Quality System.
  • To manage the control of Regulatory Information within EML.
  • To manage the TrackWise Quality Management System to ensure all electronic systems meet GxP guidelines.
  • Ensure system administration support is provided for electronic systems where an independent administrator is required to meet GMP and data integrity requirements
  • Support the Corporate Audit System as a Global Auditor.
  • Lead audits of EML (regulatory, internal and external).
  • Lead audits of external suppliers of products and services for EML and EMEA Eisai companies.
  • To manage the monthly generation of the Quality Management Systems Indicator reports.
  • To develop, manage and maintain the Regional Quality System procedures.
  • To maintain the Regional Quality System for all products within the EMEA region.
  • Provide primary support to Eisai Limited and Eisai Europe Limited as Responsible Person.
  • Provide secondary support to Eisai Manufacturing Limited as Responsible Person.
  • Identify and implement continuous improvement opportunities that result in cost savings and more efficient and compliant ways of working.
  • Prepare Management Review Reports and conduct Management Review Meetings for EML
  • To manage Quality Systems personnel, ensuring that Job Descriptions, Objectives and Appraisals are up to date and completed on time.

Skills and Requirements

  • Demonstrable Leadership and people management skills
  • Problem solving and decision-making capabilities
  • Ability to drive and lead organizational change
  • Professional behavior and self-awareness, diplomatic,
  • Ability to build, motivate and develop high performance teams
  • High level of self-awareness and ability to influence
  • Excellent communication skills
  • Excellent presentation skills
  • Effective time management
  • Auditing skills, appropriate qualifications in auditing an advantage.
  • Proficient in English, fluency in other languages is advantageous.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.