Σχετικά με την εργασία
We are seeking a Director of Quality to join our team in Wichita, KS.
As a Director of Quality, you will:
• Manage quality team and oversee all QA aspects with the aim of contributing to the organization’s
• Site responsibility for two Wichita locations
• Help create policy lines in the framework of the entire quality process, while ensuring they are
• Translate strategy into quality in actual projects utilizing generally accepted quality standards
(including ISO standards, corporate TQM, GMP, GDP, etc.) to achieve continuous improvement.
• Demonstrate adequate control and documentation of controlled substances, per state and DEA
• 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
• 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.
Ξεχωρίστε από το πλήθος
You possess the following qualifications, background and abilities:
• Experience working within GMP standards is required.
• 7+ years of experience in a quality department, ideally working in a leadership role
• 2 years related experience in compounding or pharmaceutical processing is preferred
• CAPA and/or root cause analysis experience is ideal
• Experience working with analytical testing labs
• Team leadership or management experience is required
• Technical analytical ability, and decisive judgment
• Willingness to be hands-on to mentor and educate QA team
• Self-motivated with a strong work ethic
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.