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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 M/F

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Guerbet is a leader in the medical imaging field offering health professionals innovative and effective contrast agents, medical devices and innovative solutions indispensable to diagnostic and interventional imaging to improve patients' prognosis for all major diseases and quality of life. Working at Guerbet means joining a human-scale company that aims to become a new global leader in medical imaging

 

Achieve, Cooperate, Care and Innovate are the values that we share and practice every day.

 

We are lookinng for an experienced Site Quality Manager M/F reporting to the Group Director Quality Technical Operations/Chief Pharmaceutical officer with dotted line responsibility to Site Director. 

 

The purpose of this role will be to lead and be responsible for overseeing all QA/QC efforts & GMP activities within the Guerbet Dublin site. The successful candidate will be responsible for all aspects of GMP Quality Assurance, including developing operating philosophies, establishment  and maintenance of a Quality Culture and establishing quality systems in alignment with Guerbet Global Standards and international GMP regulations. 

OUR PROPOSAL

 

Principle accountabilities, but not limited to:

  • Lead the GMP compliance efforts for API production process related to site
  • Lead the GMP compliance efforts for EU QP Release process (Drug Product Release)
  • Promote Guerbet culture of quality (1Quality) and continuous improvement across the organization
  • Monitor and audit manufacturing for GMP compliance and serve as a key contact to production regarding quality and compliance issues.
  • Develop, manage, and maintain appropriate procedures to ensure regulatory compliance. 
  • Establish and maintain key quality indicator elements, organize   quality goals and objectives. 
  • Identify, assess and incorporate best demonstrated industry practices to assure GMP and regulatory compliance with all relevant Health Authorities (HA) and applicable external regulatory requirements and applicable guidance documents.
  • Assure that Quality Systems are managed and continuously reviewed and improved for regulatory compliance and operating efficiencies.
  • Manage any third parties to which functions have been outsourced
  • Promote and communicate the Company Quality Plan and all associated policies and guidelines
  • Maintaining a Quality Risk Management system to ensure that risks are adequately controlled in accordance with current requirements
  • Improving operational performance of QA and QC departments by coaching team members
  • Manage and support all HA and other regulatory agency activities including inspections, inquiries, notifications, all and other agency associated activities.
  • Apply modern principles of quality systems and strategic planning to products and processes to achieve sustainable quality and compliance performance.

 

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  • Establish and/or improve monitoring measures for key elements related to quality goal attainment. 
  • Analyze and report product and process quality trends, and quality system integrity against internal and external guidelines, standards and regulations.
  • Supervise Quality Assurance, Quality Control, Drug Product Release and Training functions.
  • Develop and conduct training for quality and other personnel, as necessary.  Ensure that quality department personnel are trained to perform their jobs effectively and ensure an efficient operation that is well integrated.
  • Recognize need for investigation due to deviation from written procedures, conduct investigation into non-conformance, incidents/deviations and recommend disposition of the affected product/component.
  • Prepare trend reports related to in-process monitoring, deviation reports, investigation reports. Follow up with functional department for timely completion of corrective and preventive actions recommended.
  • Define/Perform annual and random audits of production, warehouse, maintenance, analytical laboratory, etc.
  • Recommend continuous improvement plans based on observation of process, vendors, data, etc. to management.
  • Ensure timely in-process/final testing of drug products.
  • Notify any problems with in-process testing results to production immediately and investigate the incident, as appropriate.
  • Maintain a thorough knowledge of appropriate standard operating procedures and applicable regulatory requirements and guidance documents.
  • Perform personnel evaluation as needed. 
  • Develop and manage to the financial budgets for overhead and staffing.
  • Perform other related duties as assigned from time to time based on company needs.

YOUR PROFILE

 

  • API/pharmaceutical Quality Assurance/Quality Control environment. Five (5) years of progressive leadership or supervisory experience in a Quality Assurance function of the pharmaceutical industry required.
  • Knowledge and experience of applicable regulatory standards and requirements for the API manufacturing required – EU and US FDA, ICH Q7a…
  • Knowledge of analysis of API utilizing UPLC/HPLC, GC, spectroscopic and wet chemistry techniques & microbiology.
  • Honours Degree (B. Sc.) in Chemistry, Microbiology or equivalent field. Masters Degree, PhD or QP qualification relevant to the role an advantage.
  • 5-10 years relevant experience of quality assurance within an FDA and European regulations environment essential.
  • Demonstrated ability to implement continuous improvement methods to improve quality and operations performance.  (Six Sigma / Lean experience or qualification an advantage)
  • 5-10 years relevant supervisory/management experience within a Quality function of healthcare/ pharmaceutical industry 
  • 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
  • Experience in computer applications such as SAP, Minitab, Microsoft Word, Excel, Access and Power Point.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. 
  • 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.