Job Description

Working under the supervision and in close collaboration with the Business Process Improvement Manager, the Process Improvement Engineer plays a key role in optimizing processes within Clario. Work with internal Clario groups and departments to implement and establish and publish harmonized processes and tools. Identify and define key metrics to enable transparency and visibility of work in process and value delivered. Responsibility for establishing, updating and maintaining Clario process flow charts, Standard Operating Procedures (SOPs), Standard Work Instructions (SWIs), Templates (TMPs), and other audit controlled documentation in harmony with the way we work. Provide and support ongoing training on processes and documentation libraries. Essential Duties And Responsibilities Supports Clario Technology organization in defining, creating and changing process workflows. Participates in process/tool integration projects within Clario and proactively manages quality related topics within each process. Occasionally leads projects for implementation of software solutions and tools (that support/enforce process) wihin Clario globally. Provides training to Clario staff on processes. Supports Technology Strategy and Governance office in development of training materials for processes. Implements methods for measuring training efficiency. Leads Process Harmonization projects and participates in Clario process harmonization or definition projects and ensures appropriate Quality and Regulatory challenges (standards and regulations from ISO, FDA and GxP and best practice approaches) are considered. Establishes methods for monitoring and measuring of processes. Reports metrics for the process performance on a regular basis. Performs analysis of process metrics and makes improvement suggestions. Other Duties And Responsibilities Perform basic trainings on Process and Supporting Tools and flow charts for Clario departments and staff. Supports Clario Quality Management team in audits or assessments from clients and authorities. Evaluates process deviations in Clario document Management System and identifies areas for improvements in Clario processes. Manages and maintains a process reference table to link process, SOPs, SWIs, and templates. Manages and maintains a process reference table from prior audits request and response results to facilitate future audit requirements. Experience QUALIFICATIONS AND SKILLS NEEDED: Required at least 3 years of experience in Quality Management (Pharmaceutical / Medical environment preferred Preferred 2 years experience in either Lean, Six Sigma, or other formal process analysis methods Ability and desire to coach and train other staff members in Clario Experience and knowledge in managing and supporting process change Experience and knowledge about regulatory requirements (cGxP) especially in ISO, FDA and ICH related requirements desirable Experience working in a global team and international environment desirable Good skills in English language - Fluent in written and speaking. Excellent organizational and communication skills Education Master or Bachelor Degree or equivalent experience in Quality Management/Assurance or Process Management. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract. The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications. Courageously Curious Our appetite to blend the best of domain expertise, technology and human understanding knows no bounds. We\'re relentless in pursuing the information, insights and inspiration that means we can continuously improve clinical trial site support services and technology solutions. Behaviors We learn; embracing change, questioning how we work, finding a better way. And if it doesn\'t go to plan, we don\'t blame each other; instead, we own it and grow together We partner\' with each other, with customers, patients and sites, working with them to understand their goals and then deliver the best solutions, Deliver Exceptional We step forward because responsibility powers us; we don\'t leave others to do what we can do ourselves. We take charge of events, delivering exceptional work for our customers, patients and each other. Behaviors We prioritize; focusing on what matters, never compromising on quality. We commit; delivering what we say we will, working with energy and intent, sharing what we learn with each other., People first, always We think of others before we think of ourselves. We have a deep understanding of our customers, and deep empathy for patients-and each other. We\'re united by our purpose-it\'s why we go above and beyond to support each other, emphatically. Behaviors We do the right thing; for our customers, patients, sites and each other. And We\'re passionate about it. We lift each other up; respectful of different views, we listen are inclusive, and support each other to succeed.

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