Process Excellence Lead

Role & responsibilities

JD- Process excellence

• Instrumental in establishing PE function within the organization.
• Drive operational efficiencies and quality improvement initiative across clinical research projects and processes.
• Collaboration with cross functional teams, identifying opportunities or process optimization, and implementing innovative solutions to ensure compliance, enhance productivity, and support organizational goals.
• Process mapping: Prepare annual planner and conduct process excellence checks for compliance and improvement areas.
• Plan process checks based on master study schedule/ensure sponsor specific requirement on random basis and prepare report.
• Prepare process workflow and detect gaps/inefficiency/bottlenecks with respect to quality, training, cost and timelines.
• Monitor the processes followed by different locations of Cliantha and ensure harmonization of processes.
• Project meeting with stakeholders/clients to understand bottlenecks/errors.
• Evaluate internal/external observations, CAPA implementation status across Cliantha locations and identify areas of improvement.
• Share points to management and respective users for process improvements
• Present PE matrix to management intermittently (Preferably every quarter)
• Communicate with Regulatory Authorities and / or sponsors when needed
• Evaluate QMS matrix such as change control, deviations, events, QA/QC observation and suggest improvement areas. Coordinate with respective team HOD and training team for training need requirement
• Perform impact assessment on major changes made in the system
• Establish SOPs, templates, checklists and best practices for process improvement across organization
• Implement tools and methodologies like Lean, Six Sigma, and CAPA to ensure consistent process quality
• Conduct unannounced audit/checks to identify vulnerabilities and recommend improvements

Preferred candidate profile

• Strong analytical and problem solving abilities
• Ability to acquire proficiency/proficient in data analysis tools and techniques
• Interpersonal, verbal and written communication skills and stakeholders management skills
• Build, develop, and maintain good working relationships with internal and external stakeholders.
• To be updated with current regulations and expectations