Quality Director

5 days ago

Phoenix, AZ, United States Katalyst Healthcares and Life Sciences Full time
Job Description:
The Quality Director will be responsible for overseeing and executing the day-to-day quality assurance and quality control operations at Client's manufacturing facilities. This role ensures that all products meet internal quality standards as well as external regulatory requirements (FDA, cGMP, 503B, etc.). The Quality Director will drive compliance, manage internal audits, and support continuous improvement initiatives in collaboration with cross-functional teams.
Responsibilities:
  • Oversee the implementation and maintenance of all quality systems, including document control, deviation management, CAPA, change control, and batch release processes.
  • Lead quality assurance (QA) and quality control (QC) teams across the manufacturing site(s).
  • Ensure site compliance with FDA, DEA, 503B, and cGMP regulations.
  • Support preparation and coordination of regulatory inspections and customer audits.
  • Manage the investigation and resolution of quality-related issues, including product complaints and deviations.
  • Review and approve standard operating procedures (SOPs), validation protocols, test methods, and quality documentation.
  • Coordinate with Manufacturing, Supply Chain, Regulatory Affairs, and R&D to ensure alignment on quality objectives.
  • Monitor quality metrics and trends, identify gaps, and lead process improvement initiatives.
  • Ensure training and development programs are in place for QA/QC personnel.
  • Maintain a strong focus on product integrity, batch record review, and timely product release.
Requirements:
  • Bachelor's or master's degree in pharmacy, Chemistry, Life Sciences, or a related discipline.
  • 15+ years of experience in quality functions within the pharmaceutical or biotechnology industry.
  • At least 5 years of leadership experience managing QA/QC teams in a cGMP environment.
  • Solid understanding of FDA, ICH, 503B outsourcing, and sterile injectable manufacturing regulations.
  • Experience supporting regulatory audits and implementing corrective actions.
  • Strong interpersonal and communication skills with a collaborative, hands-on leadership style.
  • Working knowledge of laboratory testing, equipment validation, and stability programs.
  • Experience with electronic Quality Management Systems (eQMS) such as Master Control, Veeva, or Track Wise.
  • Understanding of environmental monitoring and microbiological testing.
  • Six Sigma, ISO, or similar quality certification is a plus.

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