Senior Quality Lead, Sterile Manufacturing

ThermoFisher Scientific; Greenville (NC); On-site; USD 95,000 - 140,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Senior Quality Specialist – Project Lead to provide technical leadership and quality oversight for a sterile manufacturing environment. You will ensure compliance with pharmaceutical regulations and maintain company standards to prevent regulatory actions.

Responsibilities include leading moderately complex projects, reviewing procedures, training staff, and driving risk assessments to safeguard product quality and patient safety.

Qualifications

• Bachelor degree in technology, engineering, scientific field.
• Minimum 5 years in Quality Assurance, Quality Control, or Operations/Manufacturing.
• Strong knowledge of regulatory requirements and quality standards.

Responsibilities

• Leads projects of moderate complexity, ensuring compliance with regulations and drafting procedures.
• Oversees quality of methods, processes and products, coordinating training and process improvements.
• Reviews and approves procedures, training documents, forms, deviations, and change controls for moderate to high complexity.
• Performs risk assessments and implements controls to ensure product quality and safety.

Skills

Project Mgmt

Regulatory knowledge

Leadership

Communication

Quality systems

Education

Bachelor's degree in technology/engineering/science

Tools

Quality systems

Six Sigma

GxP

Job description

Thermo Fisher Scientific is seeking a Senior Quality Specialist – Project Lead to provide technical leadership and quality oversight for a sterile manufacturing environment. You will ensure compliance with pharmaceutical regulations and maintain company standards to prevent regulatory actions.

Responsibilities include leading moderately complex projects, reviewing procedures, training staff, and driving risk assessments to safeguard product quality and patient safety.