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Quality Systems Manager

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Job ID R0040788 Date posted Aug. 19, 2021 Location Lessines, Belgium

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Job Description

Primary duties :

  • ensure that the Quality System processes are effectively established, maintained and improved
  • manage through the site Systems Execution Leads the coordination of the Quality Systems activities including the Deviation, Change Control, Documentation, GMP training and Laboratory Information Management processes and systems.

Responsibilities

  • Manage the execution and maintenance of :
    • the Deviation Process. Ensures that deviations, associated investigations and action plans are appropriately and timely performed and documented. 
    • the Change Control Process.  Ensures Changes are appropriately documented and timely implemented.
    • the Documentation Process.
    • The GMP training quality oversight
    • Laboratory Information Management System (LIMS)
    • administration access role of analytical equipment’s. 
  • Responsible for ensuring compliance with all applicable provisions of the Takeda Quality Management System, the regulations and standards applicable to the operations.
  • Conduct gap analyses, implement Quality Management System procedures in departments and manage compliance.
  • Understand and assure conformance to applicable Takeda standards and regulations. Interface with regulators during inspections.
  • Define and manage action plans to ensure satisfactory quality metrics
  • Establish goals for the Quality Systems department in alignment with the global and site strategy, and take action as needed to ensure timely delivery of goals.
  • Responsible for the coaching, training, and development of the Quality Systems team.
  • Ensure an adequate Training and Qualification program is in place

Education and Experience Requirements

  • Bachelor’s – Master’s degree in engineering, chemistry, biology or related discipline
  • At least 5 years’ experience in Quality or related field in the pharmaceutical industry.
  • At least 5 years of leadership experience, developing people and strength in managing projects and initiatives
  • A thorough understanding of pharmaceutical quality management systems and regulations including current GMPs & GDDPs.  Experience working with regulatory agencies and/or direct interface experience with regulatory agencies during inspections preferred.

Key Skills, Abilities, and Competencies

  • Fluent in written and spoken French and English
  • Personal accountability for results and integrity.  Critical thinking, analytical, deal with ambiguity and problem solving skills. 
  • Demonstrated ability to work autonomously and to take decisions
  • Organizational and ability to innovate, lead change, deliver strong results and build the confidence as well as trust of stakeholders.
  • Experience with Continuous Improvement initiatives
  • Ability to lead multidisciplinary and multi-site projects
  • Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
  • Strong organizational skills
  • PC skills and be competent in Word, Excel, PowerPoint and SharePoint

Locations

BEL - Lessines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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