Director, Quality Operations

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

Position Summary

The Quality Director is the senior leader and decision maker for the Quality Department and Quality Management System. This position is ultimately responsible for the product quality received by the customer and the quality system integrity expected by the customer. The Quality Director is committed to relentlessly pursuing zero defect manufacturing and maintaining strong and efficient conformance to all quality expectations and compliance with all regulatory standards. This position is the decision maker for the Quality Management System deployed throughout the company. The Quality Director will oversee the health of the manufacturing processes through risk monitoring and oversee the conformance to the QMS through internal audits and management review. In addition, the Quality Director will represent the company as the Quality Representative for all external audits. This position will support sales and marketing to convey the company passion for quality to new and prospective customers. Key metrics: Customer Satisfaction, Audit non-conformances, Regulatory Compliance, Cost of Quality, Validation on Time.

Job Responsibilities

• Direct the day-to-day responsibilities and duties of personnel within the quality department.
• Perform manufacturing investigations, writing investigation reports, and facilitating corrective and preventive actions including:
• Provide management oversight for quality control, batch records, and material review board.
• Provide management oversight for all QMS documents and change control.
  • Ensure adherence to procedures.
  • Collaborate with department heads to ensure QMS supports the company needs and is efficient for the employees.
• Serve as the company Quality Representative for ISO 13485, 21 CFR part 820, 21 CFR part 4, and all associated regulatory requirements.
• Drive risk management in design, validation, and ongoing manufacturing.
• Ensure strong and efficient process validations to ensure manufacturing success.
• Drive strong internal audit program and robust management reviews.
• Drive strong quality performance and continuous improvement:
  • Customer Complaints
  • CAPA effectiveness
  • Cost of Quality with a focus on First Pass Yield and Scrap.
  • Completion on time for CAPA, Internal Audits, Management Review
  • Audit non-conformances
• Perform other duties as assigned.

Experience Requirements

• Strong communicator with an ability to provide clear directions to the company.
• Possess a passion for results and company performance.
• Must set the expectation for the company in quality mindfulness and lead by example.
• Must be able to sit and/or stand for extended periods of time.
• Must be able to climb stairs, must be able to lift and carry 25 lbs. and walk while carrying items.

Education Requirements

• Bachelor’s Degree in a scientific discipline required and A minimum of ten (10) years working experience in the medical or pharmaceutical manufacturing industry is Required. In addition, a minimum of five (5) years prior management experience Preferred.