Head of Quality & Compliance — Zero-Defect Ops

Exela Pharma Sciences LLC; Lenoir (NC); On-site; USD 150,000 - 190,000; Full time

Job summary

Exela Pharma Sciences LLC seeks a Director of Quality Operations to lead the Quality Department and the Quality Management System, ensuring product quality and regulatory compliance across manufacturing. You will drive risk management, audits, and continuous improvement, representing the company for external audits.

The role focuses on zero-defect manufacturing, conformance to regulatory standards, and collaboration with sales/marketing to convey a passion for quality to customers.

Qualifications

• Bachelor’s Degree in a scientific discipline required.
• Minimum of 10 years working experience in medical or pharmaceutical manufacturing.
• Minimum of 5 years prior 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 corrective and preventive actions (CAPA).
• Provide management oversight for quality control, batch records, and material review board.
• Provide management oversight for all QMS documents and change control.
• Serve as the company Quality Representative for ISO 13485, 21 CFR part 820, 21 CFR part 4, and related regulatory requirements.
• Drive risk management in design, validation, and ongoing manufacturing.
• Ensure strong and efficient process validations for manufacturing success.
• Drive a robust internal audit program and management reviews.
• Drive quality performance and continuous improvement: complaints, CAPA, cost of quality, on-time closures.

Skills

Strong communicator

Leadership

Quality mindset

Attention to detail

Education

Bachelor's Degree in a scientific discipline

Job description

Exela Pharma Sciences LLC seeks a Director of Quality Operations to lead the Quality Department and the Quality Management System, ensuring product quality and regulatory compliance across manufacturing. You will drive risk management, audits, and continuous improvement, representing the company for external audits.

The role focuses on zero-defect manufacturing, conformance to regulatory standards, and collaboration with sales/marketing to convey a passion for quality to customers.