Global CAPA & Deviations Manager - Quality Systems

Integrated Resources Inc.; Lexington (MA); On-site; USD 100,000 - 120,000; Full time

Job summary

A specialized healthcare solutions provider located in Lexington, MA is seeking an experienced Deviations/CAPA Manager. The role involves managing global event management processes and ensuring compliance with GMP regulations. Ideal candidates will have at least 5 years of quality experience, a Bachelor’s degree in a science field, and ASQ certification. This position demands strong expertise in deviation systems and a collaborative approach across teams.

Qualifications

• 5 years of quality experience in deviation systems is required.
• Experience with Medical Devices, Biologics, and Blood Products is advantageous.
• Ongoing training in event/deviation management is essential.

Responsibilities

• Support the Quality Lead for Deviations/CAPA as a Subject Matter Expert.
• Manage Client’s GEMS Expertise Council and support regulatory inspections.
• Develop and deploy CAPA processes across the organization.

Skills

Quality management

Deviation systems expertise

Cross-functional teamwork

Regulatory compliance

Education

Bachelor’s degree in a science related field

ASQ Certified Quality Manager

Tools

GEMS systems

Quality monitoring software

Job description

A specialized healthcare solutions provider located in Lexington, MA is seeking an experienced Deviations/CAPA Manager. The role involves managing global event management processes and ensuring compliance with GMP regulations. Ideal candidates will have at least 5 years of quality experience, a Bachelor’s degree in a science field, and ASQ certification. This position demands strong expertise in deviation systems and a collaborative approach across teams.