Quality System Specialist

Summary:

We are seeking a skilled Quality Systems Specialist to drive continuous improvement across diverse projects and systems within our organization. This role will leverage expertise in Lean Six Sigma methodologies, including DMAIC, FMEA, SIPOC, and others, to enhance operational efficiencies and ensure compliance with global regulatory standards. The ideal candidate will collaborate closely with stakeholders, acting as a Subject Matter Expert to develop sustainable Quality Systems and facilitate strategic alignment across departments such as CMC, Production, and Clinical Operations.

Key Responsibilities:

Implement and refine Quality systems using Lean Six Sigma tools to achieve measurable improvements.

Lead initiatives to close operational gaps and support business objectives.

Ensure adherence to health authority regulations by developing and updating SOPs as needed.

Utilize quality risk management principles to propose and implement process enhancements.

Collaborate effectively with cross-functional teams to harmonize processes and drive continuous improvement projects.

Requirements:

Education:

Bachelor's degree in a scientific, engineering, or related field.

Experience: Minimum 10-12 years in pharmaceutical or biotech industries; experience as a Quality Specialist preferred.

Certification: Six Sigma Black Belt certification or equivalent preferred.

Skills: Deep understanding of Quality tools and their application in achieving GxP compliance and process refinement.

Strong analytical and problem-solving skills, with the ability to communicate complex concepts effectively.

Proven track record of delivering results under tight timelines.

Additional Information:

This position does not have direct supervisory responsibilities but requires strong leadership and collaboration skills to drive impactful outcomes across the organization.