Global Site Compliance Lead - Medical Devices

BioSpace; Waco (TX); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

Paid time off

401(k) participation

Job summary

A prominent biopharmaceutical company is seeking a Site Compliance Manager to oversee Quality Engineers and ensure compliance with FDA regulations. This role involves managing project support, conducting investigations, and overseeing internal and supplier audits. The ideal candidate will have a scientific bachelor's degree and significant experience in regulatory environments. The company offers a comprehensive benefits package, including medical insurance and a 401(k).

Qualifications

• 7-8 years of related experience in a regulated industry.
• Supervisory experience preferred but not required.
• Familiarity with FDA regulations and international complaints.

Responsibilities

• Manage Quality Engineers and Quality Trainers.
• Conduct CAPA and Non-Conformance investigations.
• Oversee supplier quality compliance and audits.

Skills

Knowledge of applicable regulations

Ability to communicate and collaborate

Ability to function in a cGMPs controlled environment

Education

Bachelor's degree (scientific preferred)

Tools

TrackWise

eLMS

Job description

A prominent biopharmaceutical company is seeking a Site Compliance Manager to oversee Quality Engineers and ensure compliance with FDA regulations. This role involves managing project support, conducting investigations, and overseeing internal and supplier audits. The ideal candidate will have a scientific bachelor's degree and significant experience in regulatory environments. The company offers a comprehensive benefits package, including medical insurance and a 401(k).