Senior QA Leader: Compliance, Audits & Quality Systems

NCBioImpact; Raleigh (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

NCBioImpact in Raleigh, NC is seeking a Senior Manager of Quality Assurance to provide leadership for the QA team and ensure compliant product development across our portfolio. You will oversee FDA/regulatory programs, audits, CAPA, and supplier quality, partnering with cross-functional teams to strengthen quality systems and drive a culture of excellence.

The role demands deep regulatory knowledge, strategic thinking, and the ability to translate complex requirements into practical processes

Qualifications

• Bachelor's degree in science or related field required.
• 7-10 years of healthcare experience, preferably with medical device exposure.
• Strong knowledge of FDA regulations (e.g., 21 CFR Part 820, Part 11) and ISO standards.

Responsibilities

• Develop processes to maintain compliance with FDA regulations.
• Lead internal and external audits including clients, vendors, regulatory bodies and government agencies.
• Monitor regulatory trends and ensure inspection readiness and high quality results.
• Drive changes to quality systems with executive leadership and stakeholders.
• Provide vendor oversight to ensure regulatory compliance and quality.

Skills

Medical device experience

FDA regulations knowledge

Audit management

Regulatory compliance

Education

Bachelor's Degree in science or related field

Tools

MasterControl

Job description

NCBioImpact in Raleigh, NC is seeking a Senior Manager of Quality Assurance to provide leadership for the QA team and ensure compliant product development across our portfolio. You will oversee FDA/regulatory programs, audits, CAPA, and supplier quality, partnering with cross-functional teams to strengthen quality systems and drive a culture of excellence.

The role demands deep regulatory knowledge, strategic thinking, and the ability to translate complex requirements into practical processes