Global Quality Process Manager

Global Quality Process Manager

Sanofi

Budapest, Hungary

About the job

As per the Guideline for Good Clinical Practice, (CH-GCP E6 (#5.0)), you should implement a system to manage quality throughout all stages of the trial process (i.e. quality-by-design) and the quality management system should use a risk-based approach.

As CHC Global Quality Process Manager, you will be accountable for define, analyze, improve processes in the clinical environment to fulfill consumers/subjects needs as well as ensure human subject protection and the reliability of trial results, integrating activity elements of process improvement methodologies and tools.

About growing with us – in this role you will

• Lead the definition of straight-forward processes that fit-for-purpose to a FMCH organization;
• Document processes in a Quality Document Management System (QDMS) by writing Standard Operating Procedures (SOPs), standard working instructions, templates, records, and other reference documents;
• Define/coordinate Training Matrix/Training Plan/Training Curricula;
• Define Quality Performance Indicators (QPIs) and quality index/metrics and Write annual quality system review, and anticipate or identify gaps;
• Support risk assessments, monitor effectiveness of Risk Mitigation and Risk Prevention approaches;
• Lead the process for gathering, analyzing, and sharing of best practices and study lessons learned;
• The CHC Global Quality Process Manager also is responsible for the quality risk management activity to facilitate and improve a science-based decision making process and, ultimately, link to the protection of the consumers/subjects. (Risk assessment, identification, analysis and control);
• Define and optimize processes with process indicators and controls.

About you: qualifications, education and work experience

• Bachelor’s/Master’s degree;
• Min. 5 years of experience in clinical operations/end-to-end clinical trial processes;
• Fluent English; knowledge of additional European languages is a plus;
• Knowledge of the drug development process and worldwide GCP compliance regulations;
• Quality focused with a high degree of personal accountability and commitment;
• Strong personal leadership and multi-level interpersonal skills with demonstrated competency to influence decisions from a quality perspective;
• Good analytical skills to analyze data and interpret trends to drive action plans to improve business needs;
• Able to analyze new situations and provide guidance on a risk-based approach;
• Demonstrated ability as a proactive strategic thinker, conduct impact assessments, root cause analysis, and take the initiative for corrective measures;
• Strong project management skills, including ability to influence others without direct authority;
• Strong facilitation skills: ability to lead effective cross-location and cross-functional meetings, through discussions on complex and potentially controversial topics;
• Able to multi-task, handling a wide range of small, medium and long-term assignments in parallel.

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