Associate Director, Quality Management System, QA

Summary

The Quality Assurance (QA) department is seeking an experienced QA professional who will be responsible for assessing, improving and maintaining the Quality Management System (QMS). This is to ensure a state of cGMP compliance and support the effective execution of Quality Management Systems. The qualified candidate will partner with the Quality Assurance QMS, Sr. Director for continuous improvement of Quality Manual policies, procedures, work instructions and processes while also leading cross functionality to build a culture of quality.

Responsibilities

• Design an architectural landscape for Quality Management System.
• Assess, improve, and maintain the QMS elements including Quality Manual, policies, procedures, and controls, enabling successful and efficient processes to meet regulatory requirements.
• Interact with quality and cross functional stakeholders on the performance of quality systems.
• Ensure continuous improvement while keeping current with emerging and changing regulations, guidance documents, and industry best practices.
• Provide cross functional quality leadership and act as Subject Matter expert for, at a minimum Deviation Management, CAPA & Effectiveness Check, Change Management, Document Control, Training Management, Product Complaints, Quality Management Reviews.
• Oversee the performance and effectiveness of the Quality Management System programs as well as Quality Risk Management, Training, Documentation and Records Management, and Data Integrity.
• Monitor the state of control of Arcus Quality Management System.
• Evaluate and identify improvement opportunities, utilize critical thinking, and apply problem solving skills, to improve and sustain product quality and process effectiveness in the overall QMS lifecycle.
• Establish robust and comprehensive processes to assure corrective and preventive measure are systematically implemented and controlled.
• Lead the revision of Quality Management Systems documents. 
• Implement a training program for Arcus GxP staff to maintain compliance with regulations and internal processes and procedures. 
• Train end users of the Quality Management System.
• Provide metrics on the performance of QMS.

Qualifications

• BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.
• 15+ years of Pharma/Biotech industry experience in Quality Assurance (QA) in a GxP environment
• Direct experience with key quality systems (e.g., Change Management, Deviations Management, CAPA and Effectiveness Check, Product Complaints, Training Management, Document Control and Quality Management Review)
• Excellent working knowledge and understanding of GxP requirements, proficiency in applying regulatory and ICH guidelines.
• Broad experience in the bio-pharmaceutical industry in small molecules a