The Position

The purpose of this position within the Quality and Compliance department is to quality leadership and oversight of medical device / drug combination products development and management at Arrowhead.

This position will report to the Vice President Quality and Compliance and work closely with members of the Operations, Supply Chain, Regulatory, Quality, and Commercial teams, as well as external stakeholders and suppliers to support Quality Management System (QMS) and ensure the clinical and commercial presentations of combinational product quality and compliance with relevant laws and company's strategic goals.

Responsibilities

• Serve as an internal subject matter expert in the combinational products and primary lead for all relevant elements of QMS and quality aspects of the combinational product development and management
• Monitor, guide, and ensure internal stakeholders' decision-making and actions are consistent with cGMPs, QSR, ISO 13485, Good Distribution Practices (GDP), relevant international laws and guidances, and Arrowhead policies and procedures
• Develop and maintain quality strategy and provide quality guidance to engineering team during all phases of design control, risk management, human factor engineering, process development, verification/validation testing, packaging, and distribution, as well as lifecycle management of design changes and documentation
• Establish and maintain electronic Design History File (DHF) and Device Master File (DMF), and relevant to the combinational product elements of QMS
• Champion, maintain, and support continuous improvement to the combination product QMS, monitor and identify areas for improvement and ensure remediation
• Support development and management of Quality Agreements, external audits of suppliers, and 3rd parties within the Supply Chain
• Support internal audits, certifications, and facilitate regulatory inspections at Arrowhead and it's suppliers
• Prepare and present to management periodic reports and status of regulatory compliance of combination product, QMS, DMF, including the measures and activities to ensure compliance
• Other duties as assigned

Requirements:

• BS or BA Degree in relevant scientific or engineering discipline, and at least 8 years of relevant experience
• Strong knowledge of FDA regulations (21 CFR Part 820, 21 CFR Parts 210/211), ISO 13485, and other relevant international standards
• Experience leading QMS implementation, maintenance, and improvement initiatives, including CAPA, change control, and risk management processes
• Experience in engaging with regulatory authorities
• Competent knowledge of and ability to use Microsoft Office suite
• Prior experience with use of an electronic document management system in a regulated environment
• Ability to follow company procedures, work instructions, and policies
• Ability to process, synthesize and summarize complex issues
• Excellent judgment, and analytical, problem-solving skills
• Work in a safe manner; properly handle materials and chemicals
• Excellent attention to detail and organizational skills
• Ability to multi-task and prioritize work tasks with minimal supervision
• Excellent interpersonal, verbal, and written communication skills

Preferred:

• Master's degree
• Relevant professional certification