Purpose
The purpose of this role is to drive organizational transformation within the Quality Department by simplifying and standardizing processes, improving cycle times through performance initiatives, and implementing risk-based approaches across all quality continuous improvement processes. The CI Specialist acts as a key enabler of the site's digital transformation, supporting the transition from paper-based to digital systems while leveraging AI-driven tools to enable faster, more data-driven decision-making. The role champions the "Right First Time" principle in the execution and delivery of all projects, fostering a culture of excellence and continuous improvement throughout the organization.
Responsibilities
- Hold the role of CI Specialist in accordance with SMS 2.0 definition and standards. Facilitate cross-functional teams to identify quality improvement opportunities and implement effective solutions. Lead and manage continuous improvement projects using appropriate methodologies (e.g., Lean, Six Sigma, PDCA). Foster a culture of continuous improvement within the organization, promoting employee engagement and ownership.
- Monitor and analyze quality metrics to identify trends, areas for improvement, and potential risks. Measure the effectiveness of improvement initiatives implemented and define remediation actions when necessary.
- Contribute to quality issues investigations to identify underlying root causes and define appropriate preventive actions.
- Collaborate with production teams to implement process improvements and enhance operational efficiency. Support the implementation of new quality systems and tools, particularly those enabling digital transformation. Maintain comprehensive records of improvement activities and report on progress to stakeholders at all levels.
- Drive, develop, and maintain the CI Board under his/her scope
- Establish and prioritize quality initiatives for the area in scopeAdvise on best practices for quality management and continuous improvement
- Advise production teams on process improvement strategies
- Inform teams about best practices and their benefits
Requirements
- Bachelor's degree in a relevant field (e.g., Quality, Engineering, Science, Business) - essential. Lean Six Sigma Green Belt or Black Belt certification - highly desirable. Post-graduate qualification in Quality, Operations, or a related discipline - an advantage
- Proven experience in a continuous improvement, quality assurance, or operational excellence role within a pharmaceutical, biotech, or GMP-regulated manufacturing environment. Demonstrated experience in facilitating cross-functional teams and managing improvement projects from initiation to completion. Strong knowledge of quality management systems, cGMP, and regulatory requirements. Experience with digital transformation initiatives and AI-driven tools is a distinct advantage. Familiarity with SMS 2.0 standards and definitions is desirable
- Strong analytical and problem-solving skills, with the ability to interpret complex data and drive informed decisions. Excellent facilitation and collaboration skills, with the ability to influence and engage stakeholders at all levels. Proactive and self-motivated, with a results-oriented mindset. Strong written and verbal communication skills, with the ability to present findings and progress to diverse audiences. Ability to manage multiple projects simultaneously and adapt to changing priorities. A passion for driving cultural change and embedding a continuous improvement mindset.
