Senior Supplier Quality Auditor & Compliance Leader

Masis Professional Group; North Carolina; On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

Fully furnished temporary housing

Relocation stipend

Area exploration visits

Weekly pay

Christmas shutdown

Annual tuition reimbursement

Gym reimbursement

Company-paid life insurance

Company-paid short-term disability

Employee Assistance Program (EAP)

Annual HSA contribution

Job summary

Masis Professional Group seeks a Supplier Quality Specialist – Audits & Compliance in the Charlotte, NC area. You will develop and maintain a robust internal compliance program and lead internal and external audits to ensure FDA-regulated quality and regulatory alignment.

The ideal candidate has 5+ years in QA auditing in cGMP environments with vendor/supplier auditing, experience with 21 CFR Parts 210, 211 and 21 CFR 111, and proficiency with SAP and MS Office.

Qualifications

• Minimum 5 years QA auditing in a cGMP environment and 5 years external supplier auditing in FDA-regulated industry.
• Experience with 21 CFR Parts 210, 211 and 21 CFR 111.
• ASQ Certified Auditor (CQA) preferred.
• Proficient in MS Office applications.
• Travel 20–30% for domestic audits; international travel may be needed.
• Plan, schedule, and conduct internal and external audits for regulatory and quality compliance.
• Audit suppliers and CMOs and maintain vendor qualification programs.
• Manage SCARs and verify CAPA implementation.
• Assess findings, determine risk levels, and drive corrective actions.
• Maintain audit, supplier, and compliance documentation in QMS.
• Monitor and report audit/compliance metrics to management.
• Train cross-functional teams on quality/compliance.
• Identify compliance risks and support process improvements.
• Support regulatory inspection readiness and ongoing compliance initiatives.
• Utilize SAP and electronic quality systems to support QA activities.

Responsibilities

• Develop and maintain an Internal Compliance program.
• Perform internal and external audits to ensure regulatory and quality compliance.
• Audit suppliers and CMOs and maintain vendor qualification programs.
• Manage supplier corrective actions (SCARs) and verify CAPA implementation.
• Monitor and report audit and compliance metrics to management.
• Train cross-functional teams on quality and compliance requirements.
• Identify compliance risks and support process improvements to mitigate risk.
• Support regulatory inspection readiness and ongoing compliance initiatives.

Skills

Quality Auditing

External Audits

CGMP

FDA Regulated

MS Office

SAP

Travel 20-30%

Internal Audits

Vendor Qualification

CAPA

Education

ASQ Certified Auditor (CQA)

Tools

SAP

Electronic Quality Systems

Job description

Masis Professional Group seeks a Supplier Quality Specialist – Audits & Compliance in the Charlotte, NC area. You will develop and maintain a robust internal compliance program and lead internal and external audits to ensure FDA-regulated quality and regulatory alignment.

The ideal candidate has 5+ years in QA auditing in cGMP environments with vendor/supplier auditing, experience with 21 CFR Parts 210, 211 and 21 CFR 111, and proficiency with SAP and MS Office.