Director of Quality

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We are seeking a Director of Quality to join our North American headquarters in St. Paul, Minnesota. 

 As a Director of Quality, you will:

  • Manage quality team and oversee all QA and QC aspects with the aim of contributing to the organization’s strategy.
  • Directly supervise all compounding and aseptic personnel.
  • Determine the policy lines in the framework of the entire quality process, while ensuring they are compliant.
  • Translate strategy into quality in actual projects utilizing generally accepted quality standards (including ISO standards, corporate TQM, GMP, GDP, etc.) to achieve continuous improvement.
  • Guarantee quality within the complete flow from raw material to product and continuously strive to achieve optimum quality.
  • Assure adequate control and documentation of controlled substances, per state and DEA regulations.
  • Follow all federal, state and local laws, rules and regulations for quality and safety in the preparation of pharmaceutical products.
  • Interact regularly with federal and state agencies (FDA and DEA primarily) and serve as the contact for suppliers, customers and local authorities on the subject of quality.
  • Analyze issues and initiate and follow up on improvement projects to achieve and improve quality standards.
  • Carry out the final review of all the validation protocols, assuring quality is in line with regulations
  • Analyze and report on the results of quality controls, and prepare, manage and follow up on audits.
  • Site responsibility to address all orders related to business working with legal.

Distinguiti dagli altri

You possess the following qualifications, background and abilities:

  • Pharmacy degree and license preferred, but not required
  • Experience working within GMP standards is required.
  • 10+ years of experience in a quality department, ideally working on an international scale
  • 2 years related experience in compounding or pharmaceutical processing is preferred
  • CAPA and/or root cause analysis experience is ideal
  • Experience working and coordinating with analytical testing labs
  • Team leadership or management experience is required
  • Technical ability, analytical ability, and decisive judgment
  • Self-motivated with a strong work ethic

Cosa offriamo

Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.

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