Director of Quality

Senior Manager, Recruiting (Pharmaceutical, Biotech and Medical Device)

Our client is hiring a Director of Quality Assurance as they grow in the clinical and commercial space. The ideal candidate will have clinical GMP and/or commercial GMP experience in the pharmaceutical industry.

• Leads the Quality Assurance (QA) Department, including hiring and mentorship to the team
• Leads implementation and continuous improvement of the company’s quality systems and facility validation
• Creates product quality documentation system by writing and updating quality assurance procedures
• Leads Quality System improvements, Investigations, CAPAs, Change Management, Document Control, Validation, and Auditing
• Responsible for oversight of site activities, assuring that products are manufactured in compliance with cGMP, FDA, and EU guidelines
• Supports internal audits, client audits and regulatory inspections
• Provides support and oversight of Quality Management Review meetings
• Defines and maintains a strong people management, training, and engagement culture to ensure a high and constantly improving right first‑time rate in manufacturing and QC
• Manages the QA budget to ensure that resources are allocated appropriately and that all projects are completed on time and within budget
• Experience with regulatory inspections by the FDA and EU authorities

• Bachelor’s degree in a scientific discipline; advanced degree is preferred
• Minimum 10 years of GMP and Quality experience in the Pharmaceutical or Biotechnology industry
• Minimum 5 years in a QA management role

Director

Full‑time

Quality Assurance, Manufacturing, and Management

Pharmaceutical Manufacturing and Biotechnology Research

Location:

Bend, OR

Salary range: $90,000.00 – $ (updated 1 month ago)