QA Technical Lead

Job Title: QA Technical Lead
Location: Novato, CA
Type: Contract
Compensation: $45 - $50/hr
Work Model: Hybrid - onsite and remote

Responsibilities

• Lead Quality-related reviews, cross-functional process teams, serving as a subject matter expert for Supplier Change Notifications.
• Lead all quality aspects for the management of COMPANY's Approved Supplier List.
• Establish process to monitor SCNs through key performance indicators (KPIs), trend analysis, and regular reviews, identifying and leading opportunities for improvement.
• Serve as the Business Process Owner for SCN and ASL process(es), proactively monitoring and maintaining the health of the process and subprocesses, driving continuous improvement efforts, and sustaining compliance with current and evolving global health authority requirements and regulations.
• Review and approve Supplier Change Notifications in the QMS.
• Make decisions and act with authority to carry out actions as applicable.
• Collaborate with external/internal global and site stakeholders to identify, define, and implement opportunities for improved SCN process workflows, while aligning the process with organizational goals and strategies. Promote knowledge sharing and the best practices.
• Develop, implement, and communicate quality policies and procedures to ensure consistency across the network and alignment with global processes.
• Support implementation of program enhancements to SCN and ASL processes.
• Provide SME support to site inspections, global inspections, and related observation responses.

Requirements

• BA/BS in life sciences or related field
• 6+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry
• Knowledge and experience in GMP and GDP global regulations, principles, concepts, practices, and standards
• Prior experience and knowledge in Supplier Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory required. Knowledge in international regulatory landscape preferred.
• Demonstrated ability to work effectively in a matrix environment and drive results through "influence" as well as direct management.
• Organizational and management skills, with ability to effectively plan, schedule, execute, and track complex projects.
• Excellent interpersonal and communication skills and ability to influence diverse stakeholders and drive accountability and decision-making cross-functionally.
• Ability to present data and defend approaches in front of management and inspectors.
• Ability to partner with other functional groups to achieve business objectives.

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.