Quality Systems & CAPA Manager: Deviation & Complaints

Regulatory Toolkit; Greenville (NC); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical, Dental, Vision benefits

401K company match

Tuition reimbursement – eligible after

Employee referral bonus

Employee discount program

Recognition program

Charitable gift matching

Company paid parental leave

Career advancement opportunities

Job summary

Thermo Fisher Scientific is seeking a Manager, Quality Systems & Compliance – Deviation/CAPA/Complaints in Greenville, NC. You will lead critical quality programs to support regulatory compliance, investigations, CAPA, and customer complaints across our expanding operations.

You will manage a team of quality professionals, collaborate with cross-functional partners, and drive continuous improvement while maintaining inspection readiness.

Qualifications

• Bachelor's degree in a scientific, engineering, health-related, or closely related technical field.
• Experience in pharmaceutical or medical device quality systems.
• Strong knowledge of FDA regulations and cGMP requirements.

Responsibilities

• Lead Deviation/ CAPA/ Complaints programs and ensure compliance.
• Oversee quality investigations and root-cause analysis.
• Coordinate cross-functional quality improvements and risk-based decisions.
• Support internal and regulatory audits and inspections.
• Coach and develop a high-performing quality team.

Skills

Quality Systems

Regulatory compliance

Investigations

CAPA

Leadership

Cross-functional

Quality metrics

Inspection readiness

Education

Bachelor's degree in scientific/engineering/health-related field

Tools

TrackWise

Veeva Vault

MasterControl

Job description

Thermo Fisher Scientific is seeking a Manager, Quality Systems & Compliance – Deviation/CAPA/Complaints in Greenville, NC. You will lead critical quality programs to support regulatory compliance, investigations, CAPA, and customer complaints across our expanding operations.

You will manage a team of quality professionals, collaborate with cross-functional partners, and drive continuous improvement while maintaining inspection readiness.