Director of Quality Operations & Compliance

Regulatory Jobs; North Carolina; On-site; USD 120,000 - 190,000; Full time

Job summary

Regulatory Jobs is seeking a Quality Director to lead the Quality Department and oversee the QMS in a high‑regulation medical/pharma manufacturing setting. You will drive CAPA, audits, and risk management while ensuring product quality and regulatory conformance across the organization.

The role requires a scientific degree and a decade in manufacturing with management experience; strong leadership and cross-functional collaboration are essential.

Qualifications

• Bachelor’s degree in science; 10+ years in medical/pharmaceutical manufacturing required.
• Minimum 10 years in medical/pharmaceutical manufacturing.
• Minimum 5 years senior management experience preferred.

Responsibilities

• Direct the day-to-day responsibilities and duties of personnel within the quality department.
• Perform manufacturing investigations, writing investigation reports, and facilitating CAPA activities.
• Provide management oversight for quality control, batch records, and material review board.
• Oversee all QMS documents and change control; ensure adherence to procedures.
• Collaborate with department heads to ensure QMS supports company needs and efficiency.
• Act as Quality Representative for ISO 13485 and 21 CFR parts 820/4 and related regulatory requirements.
• Drive risk management in design, validation, and ongoing manufacturing.
• Ensure robust process validations for manufacturing success.
• Lead internal audit programs and management reviews.
• Drive quality performance and continuous improvement: complaints, CAPA, cost of quality; on-time completion.
• Perform other duties as assigned.

Skills

Quality leadership

Regulatory compliance

ISO 13485 expertise

CAPA / nonconformance handling

Cross-functional collaboration

Education

Bachelor’s Degree in a scientific discipline

Job description

Regulatory Jobs is seeking a Quality Director to lead the Quality Department and oversee the QMS in a high‑regulation medical/pharma manufacturing setting. You will drive CAPA, audits, and risk management while ensuring product quality and regulatory conformance across the organization.

The role requires a scientific degree and a decade in manufacturing with management experience; strong leadership and cross-functional collaboration are essential.