Title:  Director, Quality Unit - 503B

Director – Quality Unit – 503B Compounding Business - INJECTABLES

The Director of Quality Unit handles several key responsibilities to ensure the highest standards of quality and compliance.  This role requires hands-on leadership and a deep understanding of the compounding process as this role also requires a comprehensive knowledge of the specific regulations governing 503B outsourcing facilities, which are distinct from those for traditional pharmaceutical manufacturing. The FDA’s guidelines for 503B facilities are more stringent in certain areas, particularly regarding sterility and batch testing.

Key Responsibilities:

1. 1. Quality Assurance and Control:
      • Oversee the development and implementation of quality assurance programs targeted at 503B processes.
      • Manage the quality of compounded medications, which can be more complex due to the customization and variability in formulations. This includes ensuring the sterility and stability of our compounded products.
      • Ensure compliance with FDA regulations and cGMP
      • Conduct regular audits and inspections to maintain quality standards.
      • Take active leadership in FDA and other Health Authorities audits
   2. Team Leadership:
      • Lead and mentor the quality unit team.
      • Provide training and development opportunities for staff.
      • Foster a culture of continuous improvement and quality excellence.
   3. Regulatory Compliance:
      • Maintain up-to-date knowledge of regulatory requirements.
      • Ensure all products meet regulatory standards before release.
      • Manage documentation and reporting for regulatory submissions.
   4. Operational Oversight:
      • Direct oversight of compounding processes, including aseptic techniques and equipment validation.
      • Oversee batch record creation, materials testing, and quality systems.
      • Lead investigations into non-conformances and implement corrective actions.
      • Ensure proper aseptic techniques and equipment validations are followed.
   5. Collaboration:
      • Work closely with compounding pharmacists, other departments such as manufacturing, R&D, Regulatory Affairs and supply chain.
      • Participate in cross-functional teams to address quality issues and improve processes.

Qualifications:

• • Education: Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related field.
  • Experience: Extensive experience in pharmaceutical quality assurance/control, preferably in a 503B compounding environment.
  • Skills: Strong leadership, communication, and problem-solving skills. Proficiency in quality management systems and regulatory compliance.

This role is crucial for maintaining the integrity and safety of our compounded products, ensuring they meet the necessary standards for patient care.