Senior Director, Quality & QMS Excellence

Exela Pharma Sciences LLC; North Carolina; On-site; USD 180,000 - 260,000; Full time

Job summary

Exela Pharma Sciences LLC seeks a Quality Director to lead the Quality Department and Quality Management System, ensuring product quality and regulatory conformance. You will direct investigations, CAPA, audits, and management reviews, while representing the company during external audits.

The role requires ten years in medical/pharma manufacturing, five years leadership, and a relentless focus on zero-defect manufacturing and risk management.

Qualifications

• Bachelor’s Degree in a scientific discipline; 10+ years in medical/pharma manufacturing (Required).
• Minimum of five (5) years prior management experience (Preferred).
• Ability to communicate clearly and lead by example (from Experience Requirements).

Responsibilities

• Direct the day-to-day responsibilities and duties of personnel within the quality department.
• Perform manufacturing investigations and facilitate corrective and preventive actions.
• Provide management oversight for quality control, batch records, and material review board.
• Oversee all QMS documents and change control, ensuring adherence to procedures.
• Serve as Quality Representative for ISO 13485, 21 CFR 820/4, and regulatory requirements.
• Drive risk management in design, validation, and ongoing manufacturing.
• Ensure process validations for manufacturing success.
• Drive internal audit program and management reviews.
• Drive quality performance and continuous improvement: CAPA, audits, non-conformances, first pass yield and scrap.
• Perform other duties as assigned.

Skills

Strong communicator

Results oriented

Leadership

Physical stamina

Education

Bachelor’s Degree in a scientific discipline

Job description

Exela Pharma Sciences LLC seeks a Quality Director to lead the Quality Department and Quality Management System, ensuring product quality and regulatory conformance. You will direct investigations, CAPA, audits, and management reviews, while representing the company during external audits.

The role requires ten years in medical/pharma manufacturing, five years leadership, and a relentless focus on zero-defect manufacturing and risk management.