What are the responsibilities and job description for the Director of Quality position at Germer International - Pharmaceutical Recruiting?
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.
- Requires a minimum of 10 years of GMP and Quality experience in the Pharmaceutical or Biotechnology industry
- Requires a minimum of 5 years in a QA management role