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
strategy.
• Site responsibility for two Wichita locations
• Help create 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.
• Demonstrate 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.
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
Τι προσφέρεται;
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.