Lead, Audits & Inspections Quality Assurance

Regulatory Jobs; Greenville (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

Regulatory Jobs is seeking a Senior Manager, Quality Systems & Compliance-Audits & Inspections to oversee regulatory audits and inspections programs. Responsibilities include coordinating mock inspections, leading CAPA processes, and ensuring compliance with GMPs and ISO standards.

The role requires extensive experience in pharmaceutical/medical device quality systems, strong leadership, and effective cross-functional communication to support audits and regulatory reviews.

Qualifications

• Bachelor's degree in a scientific, information management, engineering, or related field.
• 7+ years of supervisory or managerial experience with direct reports.
• 10+ years of experience in the pharmaceutical or medical device industry.
• 7+ years of experience in quality assurance and/or quality systems within the pharmaceutical or medical device industry.

Responsibilities

• External Audit Preparation & Execution: Oversee audits and be the primary client contact.
• Inspection Readiness & Execution: Plan and manage mock and actual inspections with health authorities.
• Documentation & Record retention: Ensure proper documentation support for audits/inspections.
• CAPA Management: Coordinate review and response to observations and corrective actions.
• Communications: Ensure awareness and cross-functional support for audits/inspections.
• People Management: Lead, mentor, and coach staff to maintain compliance.

Skills

Quality leadership

Audit management

Regulatory compliance

Cross-functional collaboration

CAPA management

Documentation control

Education

Bachelor's degree in a scientific/engineering field

Tools

Documentum

Veeva Vault

TrackWise

Job description

Regulatory Jobs is seeking a Senior Manager, Quality Systems & Compliance-Audits & Inspections to oversee regulatory audits and inspections programs. Responsibilities include coordinating mock inspections, leading CAPA processes, and ensuring compliance with GMPs and ISO standards.

The role requires extensive experience in pharmaceutical/medical device quality systems, strong leadership, and effective cross-functional communication to support audits and regulatory reviews.