Senior Manager, 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. The ideal candidate should have experience in small molecules and large molecules. This position is Hybrid in Hayward, CA. 

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 (SME) for, at a minimum Deviation Management, CAPA & Effectiveness Check, Extension, Internal Change Control, Software Change Control, Document Control, Training Management, Product Complaints, and Quality Management Reviews and Metrics.
• Oversee the performance and effectiveness of the Quality Management System (QMS) programs as well as Quality Risk Management, Training, Documentation and Records Management, and Data Integrity.
• Provide Quality oversight of validation GxP computer systems including documentation and procedures.
• Monitor the state of control of Arcus QMS.
• Experience in Veeva processes and systems
• 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 ensure corrective and preventive measures are systematically implemented and controlled.
• Lead the revision of Quality Management Systems documents. 
• Train end users on Deviation Management, CAPA, Change Control, and other QMS processes.
• Provide metrics on the performance of QMS and present during QMR.
• Other responsibilities as assigned. 

Qualifications

• BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.
• 10+ years of Pharma/Biotech industry experience in Quality Assurance (QA) in a