Global Quality Management System (QMS) Manager

• GuerbetSUMMARY Global Quality Management System Manager that would be responsible for:
• The overall Group Quality Management System by issuing or revising policies and guidelines
• Self-Inspection Program
• Quality Management Review processes
• Assurance of consistency for monitoring practices, KPIs, and field action prevention
• Regulatory surveillance The Global QMS Quality Manager also serves as the quality leader for strategic initiatives such as QMS & audit harmonization and OPEX Continuous Improvements Initiatives.

• Ensure that Group Policies & Guidelines are created and maintained in line with regulatory and Guerbet Standards.
• Effectively manage Global Quality Management System activities and processes to ensure the Global Compliance function is appropriately supported to meet functional needs.
• Provide guidance, management and accountability for ensuring that Group Quality Management System (Policies and Guidelines) are developed, implemented and maintained to lead efficient working practices across the company,
• Challenge current procedures and practices to afford optimization and further development of existing quality standards and overall compliance
• Ensure the department proactively develops effective compliance strategies and operational plans that meet business goals
• Identify and assess risk and the chance of success and offer solutions and recommendations on operational issues and make decisions under conditions of uncertainty
• Prepare and deliver Quality System trainings
• Manage Global Quality SharePoint to develop a Quality System Community
• Perform Global Quality Management Review and track actions defined
• Maintain updated the Global Guerbet Quality Manual
• Ensure that the internal audits, self-inspections, Heath Authorities inspections and key auditing systems are effectively implemented, revised and optimized to ensure a continuous drive to improve product and process quality at the sites and DCs’ level.
• Establish the Audit Master Plan of Guerbet sites/functions/local affiliates
• Conduct some corporate audit and ensure that all corporate audits are efficiently done on time
• Ensure the certification of all Corporate auditors and prepare and deliver annual certification training.
• Be responsible for establishing the template of Quality Agreements with our third parties or local affiliates.
• Establish and maintain the update of the Quality Agreements between Guerbet or sisters Guerbet entities to define roles and responsibilities
• Define, trend and analyze KPI with the Global Quality Support Manager to develop appropriate action plan when necessary
• Monitor the external environment and perform regulatory surveillance, with a view to influencing changes to the benefit of the business and adapting compliance activities proactively.
• Contribute strategically to the business.

• Lead divisional projects across internal and/or external sites
• Represent Guerbet in external forums, conferences, and working groups such as A3P, SFSTP, ISPE, PDA, EP or USP.

• Pharmacist or Quality Engineering
• At least 5-10 years of pharmaceutical industry and or Medical Devices experience, including 3-5 years in Quality department.

• Knowledge of FDA, EMA and/or ICH guidelines
• Knowledge of a new product introduction process
• Knowledge of Quality Management Systems
• Able to accommodate modest amount of domestic travel.
• Ability to manage multiple responsibilities with high degree of self-motivation.
• Excellent English knowledge, both spoken and written.

• Preferred Skills:
• Excellent verbal and written communication skills.

• This position requires demonstration of strong management/leadership skills with advance communication and analytical skills, with a proven track record in regulatory inspections.
• Ability to communicate information with courtesy and tact
• Highly self-motivated
• Strong organizational & Presentation skills
• Flexibility
• Initiative and mature judgement
• Experiences from developing and deploying improvement concepts and leading improvement projects across cultures and regions.
• Knowledge of theories, tools and practices in quality improvement & change management
• Must be able to innovate, analyze, and solve problems with minimal supervisory input.
• Fluent written and spoken English matched with good communication and training skills.
• Strong analytical and systemic problem solving skills.
• Clear passion to develop and change self and others.
• High personal integrity
• 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.

• Are choosing the world’s leader in the technological sector of diagnostic and interventional imaging,
• Are joining our 2850 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life in more than 80 countries all over the world,
• Are joining a company where we value our diverse team coming from various horizon.

We # Achieve # Cooperate # Care # Innovate at Guerbet.