Overview
Director, Site Quality Operations Jobs in Gilbert, Arizona, USA at Startops
Position: Director, Site Quality (arizona) Operations
Director, Site Quality (Arizona)
Lead the development and implementation of quality systems for a compounding facility.
** Gilbert, Arizona, United States
Job ** Operations
About The Role
The Director of Site Quality will develop and implement quality systems for a 503a registered compounding facility.
This role involves leading Quality Assurance and Control systems for the production of solid oral dosage, Rx, and OTC products.
The Director will collaborate with Operations leadership to foster a culture of Quality by Design and Continuous Improvement.
Responsibilities include approving and releasing all compounded products and managing regulatory inspection activities.
The position requires oversight of Quality Assurance and Quality Control documentation, ensuring compliance with industry standards.
Qualifications
A successful candidate will have a bachelors degree in Science or Pharmacy, with a preference for advanced degrees.
The ideal individual will possess over 8 years of experience in Quality Assurance, particularly in environments adhering to current Good Manufacturing Practices.
Experience with 503A and 503B Outsourcing facilities or pharmaceutical manufacturing is essential for this role.
The candidate should demonstrate strong leadership skills, having managed teams in a cross-functional and possibly remote setting.
A deep understanding of cGMP requirements and FDA regulations is crucial for ensuring compliance and quality standards.
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Title: Director, Site Quality Operations
Company: Startops
Location: Gilbert, Arizona, USA
Category: Quality Assurance – QA/QC, Management
