Société : Guerbet
SUMMARY 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. ESSENTIAL FUNCTIONS: The Quality Management System Manager is responsible to: ? 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. To provide proactive QMS advice and expertise to Technical Operations on a global basis. ? 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. Required Skills & Background Minimum Requirements ? Pharmacist or Quality Engineering ? At least 5-10 years of pharmaceutical industry and or Medical Devices experience, including 3-5 years in Quality department. In-depth understanding of quality and compliance aspects of pharmaceutical development and manufacturing. ? 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. Fluency in other languages (e.g. French) advantageous. ? Preferred Skills: ? Excellent verbal and written communication skills. Ability to write reports, and required documentations. ? 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. Reasons to join us Much more than a competitive salary, we offer continued personal development, we offer an interesting opportunity to join our International Team. When you join Guerbet Group, you ? 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.