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Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

Site Quality Manager

Description

SUMMARY OF POSITION:

 Lead and be responsible for overseeing all QA/QC efforts & GMP activities within Guerbet Raleigh site.

 Responsible for all aspects of GMP Quality, including developing operating philosophies, establishment and maintenance of a Quality Culture and establishing quality systems in alignment with Guerbet Global Standards and international cGMP regulations. 

 ESSENTIAL FUNCTIONS:

 Assist in formulating the company's future direction and supporting tactical initiatives

Promote Guerbet culture of quality (1Quality) and continuous improvement across the organization

Maintain in-depth relations with all members of the management team

Leading the Site Quality Unit - Operational Quality Assurance, Quality System/Compliance, Qualification/Validation & Quality Control

Manage any third parties to which functions have been outsourced

Implement operational best practices, controls, systems, etc.

Provide daily, weekly, monthly, quarterly, annual reporting as deemed by your supervisor

Promote and communicate the Company Quality Plan and all associated policies and procedure

Participate in the implementation of strategic business plans

Actively participate in Site Leadership Team Meeting

Manage capital requests and group’s budget

Develop performance measures that support the company's strategic direction Operations

Lead continuous improvement initiatives in all Quality departments.

Serve as lead instructor of quality, lean and continuous improvement training

Facilitate and mentor Lean Kaizen events, root cause analysis, countermeasure development and process improvement teams

Developing and implementing Data Integrity Governance

Monitoring and controlling all Quality Assurance Operations, Quality System/Compliance & Quality Control systems to ensure compliance with US/EU/WHO/Brazilian/Korean standards, covering GMP procedures

Maintaining a Quality Risk Management system to ensure that risks are adequately controlled in accordance with current requirements

Acting as the main point of contact on all Quality matters, internally and externally;

Coordinating/Managing all internal audits and inspections

Improving operational performance of QA and QC departments by coaching team members

Ensuring the development of current SOPs (revising in required cases and approving), ensuring that all activities are performed in accordance with GMP, company Policies & Guidelines and Health and Safety policies

Perform personnel evaluation as needed

Perform other related duties as assigned from time to time based on company needs

Required Skills & Background

Technical/Functional (Line) Expertise

  • Knowledge and experience of Pharmaceutical Manufacturing
  • Deep knowledge and understanding of relevant regulations (FDA, EMA, PIC/S, WHO, etc.) enabling effective partnerships across the network
  • Knowledge and understanding of global and local Quality and Regulatory concepts and requirements (e.g. ICH, EU GMP Annex 1, Compendia, etc.)
  • Knowledge and understanding of relevant technologies and digital solutions desired
  • Responsible for active and timely Incident notifications and associated escalation activities

    Leadership
  • Effective communicator
  • Ability to lead effectively through directing change as well as driving change by influence
  • Ability to lead and engage in complex investigations and propose sound, scientific, and compliant resolutions
  • Ability to act locally as well as engaging to support global activities
     
    Preferred Skills
  • Candidates with good communication and team management & coaching skills will be preferred
  • Advance level of written and verbal communication skills with the ability to read, technical procedures or governmental regulations.
  • Excellent verbal and written communication skills. Ability to write reports and required documentations. Ability to communicate information with courtesy and tact
  • Highly self-motivated
  • Strong organizational skills
  • Flexibility
  • Strong Presentation skills
  • Initiative and mature judgement
  • Accuracy and attention to detail and completeness of tasks
     
    Reasoning Ability: 
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
     
    Supervisory Controls
  • Effectively manage competing priorities, adaptable to change, demonstrated ability to accept additional responsibilities and manage tasks through teamwork. 
  • Demonstrated abilities to provide direction to employees, establishes the overall objectives and resources available, broadly defines missions and functions to the employees. 
  • Assures that finished work and methods used are technically accurate and in compliance with established guidelines and procedures. 
Education

<span style="font-family:"Calibri",sans-serif">MINIMUM REQUIREMENTS:

<span style="font-family:"Calibri",sans-serif"> 

  • <span style="font-family:"Calibri",sans-serif">Bachelor's degree (B. S.) from four-year college or university in quality, business, industrial technology, science, engineering or related major
  • <span style="font-family:"Calibri",sans-serif"><span style="font-family:"Calibri",sans-serif">MBA, MS or other advanced degree preferred
  • <span style="font-family:"Calibri",sans-serif"><span style="font-family:"Calibri",sans-serif">Requires a minimum of 12 years of experience in quality engineering and/or continuous improvement in progressing roles of management responsibility
  • <span style="font-family:"Calibri",sans-serif"><span style="font-family:"Calibri",sans-serif">ASQ Certified Quality Engineer and/or ASQ Certified Manager of Quality/Organizational Excellence
  • <span style="font-family:"Calibri",sans-serif"><span style="font-family:"Calibri",sans-serif">Experience must include successful examples of managing global change by influence.
  • <span style="font-family:"Calibri",sans-serif"><span style="font-family:"Calibri",sans-serif">Strong focus on delivering global results as well as building site capability to demonstrate effective governance
  • <span style="font-family:"Calibri",sans-serif"><span style="font-family:"Calibri",sans-serif">Extensive global pharmaceutical industry knowledge
  • <span style="font-family:"Calibri",sans-serif"><span style="font-family:"Calibri",sans-serif">Fluent in written and spoken English.


Nearest Major Market: Raleigh