Senior Manager, Quality Systems & Audits & Inspections

Regulatory Jobs; Greenville (NC); Sur place; USD 130 000 - 180 000; Plein temps

Résumé du poste

Regulatory Jobs in Greenville, NC is seeking a Senior Manager of Quality Systems & Compliance to oversee audits and inspections within pharma/medical device environments. This role ensures compliance with 21 CFR, ISO standards, and ICH Q9/Q10, while leading cross-functional teams.

The successful candidate will manage external audits, readiness for health authorities like FDA and MHRA, and drive CAPA and documentation control across the organization. A strong leadership background is essential.

Qualifications

• Bachelor's degree in science or engineering or related field.
• Minimum 7 years supervisory/managerial experience with direct reports.
• At least 10 years in pharmaceutical/medical device industries.
• Minimum 7 years in quality assurance or quality systems.

Responsabilités

• External Audit Preparation & Execution: oversee audits and serve as main contact.
• Inspection Readiness & Execution: plan and manage mock/actual inspections by health authorities.
• Documentation & Record retention: ensure key docs are stored properly.
• CAPA Management: track and verify corrective/preventive actions.
• Communications: enable cross-functional awareness for audits/inspections.
• People Management: lead and develop team members on quality matters.

Connaissances

Audit leadership

Regulatory compliance

Cross-functional leadership

CAPA management

Documentation control

Communication

Training & coaching

Formation

Bachelor's degree in science/engineering

Outils

Veeva Vault

Documentum

TrackWise

Description du poste

Regulatory Jobs in Greenville, NC is seeking a Senior Manager of Quality Systems & Compliance to oversee audits and inspections within pharma/medical device environments. This role ensures compliance with 21 CFR, ISO standards, and ICH Q9/Q10, while leading cross-functional teams.

The successful candidate will manage external audits, readiness for health authorities like FDA and MHRA, and drive CAPA and documentation control across the organization. A strong leadership background is essential.