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 GxP environment
• Direct experience and deep understanding of key Quality Systems (e.g., Change Management, Deviations Management, CAPA and Effectiveness Check, Extension Request, 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 and large molecules.
• Experience developing and reporting quality metrics.
• Excellent working knowledge of quality systems and GxP standards applicable to product life cycle from development to commercial.
• Ability to prioritize and partner with other functions to meet deadlines efficiently.
• Ability to provide internal training i.e. SOPs and Policies with excellent public speaking skills.
• Proficient with the Visio, Microsoft Office software, including Word, Excel, PowerPoint experience with Project a plus.
• Knowledge and experience of Veeva System

Core Competencies

• Strong people-person who engage and motivate a team of professionals.
• Demonstrates accountability in a fast-paced environment and work independently with high degree of flexibility.
• Demonstrates positive attitude, and excellent interpersonal verbal and written communication.
• Ability to work effectively in a team environment with exceptional organizational skills, communication skills and attention to details.
• A self-starter individual, highly motivated with high level of initiative and strategic planning
• Provide clear directions to internal stakeholders.
• Customer Service approach

This role will be based at our Hayward, CA location. The anticipated salary range for fully qualified candidates applying for this position is $160,000 - $175,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers. 

Salary : $160,000 - $175,000