Quality Assurance Director

1 week ago


Malvern, Pennsylvania, United States Medix™ Full time
Job Title: Quality Assurance Director

We are seeking a seasoned Quality Assurance professional to lead our Quality Management System and ensure compliance with cGMPs and company standards.

Key Responsibilities:
  • Oversee the execution of the Quality Management System, including inspection readiness, regulatory inspections, and compliance with local and international regulations.
  • Lead and develop the Quality team, setting objectives, overseeing performance, and managing the team's work agenda and budget.
  • Ensure the site's quality systems are robust, including batch record evaluation, material release, and adherence to GMP standards.
  • Lead critical projects for quality improvement and facility expansion, ensuring alignment with strategic objectives.
  • Promote a safe work environment, ensure staff are trained in GMP and company policies, and develop team capability.
Requirements:
  • Bachelor's degree in a scientific field (e.g., chemistry, microbiology, engineering).
  • Minimum 5 years in the pharmaceutical industry with at least 5 years in Quality Assurance & Control leadership.
  • Proficiency in Microsoft Office and technical writing.
  • Strong oral and written communication skills.
  • Ability to coach, mentor, and lead effectively.
  • In-depth knowledge of cGMPs and regulatory guidelines.

Medix™ is committed to excellence and integrity in all aspects of our business. If you are a proactive leader with a strong background in quality management, we invite you to apply for this exciting opportunity.



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