Quality Audit & Regulatory Readiness Lead

Experis Austria; Greenville (NC); On-site; USD 51,000 - 73,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Health Flexible Spending Account

Dependent Care FSA

Life Insurance

Short/Long Term Disability Insurance

Business Travel Insurance

401(k) with Match

Weekly Pay

Job summary

Our client in Greenville, NC is seeking a Quality Specialist III to join the Quality organization supporting audits and inspections. The role requires leading internal, client, and regulatory audit programs and ensuring inspection readiness with health authorities such as FDA, EMA, ANVISA, and MHRA.

The ideal candidate will have a Bachelor's in a scientific/engineering/health field, 5+ years in pharma/medical devices, and 8+ years in quality focusing on deviations and CAPAs, with strong

Qualifications

• Bachelor's degree in a scientific, engineering, or health-related field.
• At least 5 years of experience in the pharmaceutical or medical device industry.
• At least 8 years of experience in quality within the pharmaceutical or medical device industry focusing on deviation management, pharmaceutical operations, quality assurance, or related areas.
• Strong working knowledge of 21 CFR Part 210/211, 21 CFR Part 600, 21 CFR Part 820, ISO 13485, ISO 9001, and ICH Q9/Q10.
• Proficiency with electronic quality management systems (Documentum, Veeva Vault, TrackWise) and strong communication, organization, and problem-solving skills.

Responsibilities

• Execute and maintain internal, client, and regulatory audit programs to support quality compliance.
• Coordinate external audit preparations including scheduling, hosting, and responses to findings.
• Support inspection readiness with mock and actual regulatory inspections (FDA, EMA, ANVISA, MHRA).
• Track, trend, and analyze audit data and quality issues to identify systemic risks and drive improvement.
• Monitor deviations and CAPAs, ensuring timely responses and effectiveness checks.

Skills

Audit & inspections

Deviation management

Regulatory compliance

Quality systems

Cross-functional collaboration

Education

Bachelor's degree in science/engineering/health

Tools

Documentum

Veeva Vault

TrackWise

Job description

Our client in Greenville, NC is seeking a Quality Specialist III to join the Quality organization supporting audits and inspections. The role requires leading internal, client, and regulatory audit programs and ensuring inspection readiness with health authorities such as FDA, EMA, ANVISA, and MHRA.

The ideal candidate will have a Bachelor's in a scientific/engineering/health field, 5+ years in pharma/medical devices, and 8+ years in quality focusing on deviations and CAPAs, with strong