Senior Quality Compliance Specialist

Job Summary

Providing independent quality and regulatory oversight, the full-time Senior Quality Compliance Specialist will evaluate SDLC practices, conduct routine software audits, and identify compliance gaps in computerized systems and digital solutions within a regulated environment.

Key responsibilities

• Conduct independent quality and regulatory oversight of computerized systems through routine internal audits
• Participate in risk assessments and evaluate regulatory and product quality risks associated with software-enabled processes
• Ensure alignment of internal procedures and governance models with evolving regulatory expectations and quality management systems

Required qualifications

• Bachelor's degree in Science, Engineering, Quality, Computer Science, IS, Regulatory Affairs, or a related field
• 5+ years of experience in Quality, Regulatory Affairs, Compliance, or Software Quality Assurance in a regulated industry
• Knowledge of 21 CFR Part 11, Computer Software Assurance, and Quality Risk Management principles
• Experience with internal auditing and regulatory inspection practices
• Ability to collaborate with diverse teams and influence stakeholders effectively