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Quality Assurance Manager

2 months ago

Malvern, United States Medix™ Full time

Overview:

We are seeking a QA professional to lead and manage our Quality Management System. This role ensures compliance with cGMPs and company standards, overseeing all quality assurance and control functions for active pharmaceutical ingredients and intermediates. The Director will drive productivity through metrics, support business objectives, and foster a quality culture aligned with our values of customer focus, integrity, collaboration, and innovation.


Responsibilities:

  • Quality Management: Oversee the execution of the Quality Management System, including inspection readiness, regulatory inspections, and compliance with local and international regulations.
  • Leadership: Serve as the Site Quality Leader, managing and developing the Quality team. Set objectives, oversee performance, and manage the team’s work agenda and budget.
  • Compliance & Oversight: Ensure the site’s quality systems are robust, including batch record evaluation, material release, and adherence to GMP standards. Review and approve GMP documentation and quality agreements.
  • Continuous Improvement: Lead critical projects for quality improvement and facility expansion, ensuring alignment with strategic objectives.
  • Safety & Training: Promote a safe work environment, ensure staff are trained in GMP and company policies, and develop team capability.


Management & Organization:

  • Uphold company values of Integrity, Excellence, and Respect.
  • Ensure effective training and adherence to ethics and compliance policies.
  • Manage resources, including headcount and budget, to meet quality objectives and business needs.
  • Actively recruit, coach, and develop the Quality team.


Quality Compliance:

  • Maintain the independence of the Site Quality Unit.
  • Ensure systems for evaluating and releasing materials, approving specifications, and maintaining compliance are in place.
  • Lead audit and inspection readiness, ensuring timely resolution of regulatory commitments.
  • Participate in site leadership and quality lead teams.


Basic 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.


Additional Skills:

  • 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.
  • DEA compliance knowledge.


If you are a proactive leader with a strong background in quality management and a commitment to excellence, we invite you to apply.