Germer International - Pharmaceutical Recruiting
Director of Quality
Germer International - Pharmaceutical Recruiting, Redmond, Oregon, United States, 97756
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.
Duties and Responsibilities
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
Education and Experience
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
Seniority level Director
Employment type Full‑time
Job function Quality Assurance, Manufacturing, and Management
Industries Pharmaceutical Manufacturing and Biotechnology Research
Location: Bend, OR
Salary range: $90,000.00 – $120,000.00 (updated 1 month ago)
#J-18808-Ljbffr
Duties and Responsibilities
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
Education and Experience
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
Seniority level Director
Employment type Full‑time
Job function Quality Assurance, Manufacturing, and Management
Industries Pharmaceutical Manufacturing and Biotechnology Research
Location: Bend, OR
Salary range: $90,000.00 – $120,000.00 (updated 1 month ago)
#J-18808-Ljbffr