Director of Product Complaints & Surveillance

• Drive execution of the global complaints business process and continuous improvement
• Maintain oversight of complaints throughout the lifecycle from intake, processing, and through closure
• Apply in-depth knowledge and subject matter expertise to determine the steps necessary to improve the complaint management system to address the root causes for the complaints
• Provide accurate and robust surveillance information that meets global health authorities and Amgen requirements
• Manage the Business Performance team for Combination Product Quality at AIN to ensure timely completion of goals and objectives.
• Leverage expertise and effectively engages with technical functions to translate risk assessments into complaint codes and decision trees and ensure continual alignment with regulatory filings
• Manage data sources used for trending, provide necessary data to technical teams for advanced analysis
• Ensure alignment between linked product complaint and adverse events investigations with Safety
• data and support for requests from global health authorities regarding the complaints process.
• Communicate potential product quality or business risks to leadership
• Escalate critical issues and findings to ensure incorporation into Management Review
• Contribute to inspection readiness activities
• Lead cross-functional initiatives to improve and strengthen complaint management system and processes at Amgen
• Interpret SOPs and regulatory requirements
• Own Process Standards, Process Overview and SOPs and ensures alignment with document hierarchy and templates
• Set project timelines and priorities for key initiatives and/or team activities
• Provide guidance and technical advice to key stakeholders involved in managing complaints
• Lead and develops a team, providing staff member supervision and on-going coaching
• Drive Operational Excellence as it pertains to complaint management processes and system
• Strategically plan, analyze, and manage resources to include budget, contractors, staff, etc.
• Act upon performance metrics and process issues, implementing actions to drive continuous improvement and escalation to management if needed

Basic Qualifications:

• Doctorate degree and 8 years of Quality experience
• Masters degree and 15 years of Quality experience
• Bachelors degree and 20 years of Quality experience 
• 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• Advanced Degree in a Science Field
• Combination products (medicinal product and device) expertise
• Strong problem solving and data driven analytics
• Strong leadership skills and the ability to oversee multiple projects simultaneously
• Able to successfully manage workload to meet timelines
• Able to respond and provide astute advice quickly in difficult scenarios or in response to tough questions
• Strong change management skills
• Familiarity with basic project management tools
• Ability to negotiate a strategic position after taking feedback from multiple sources
• Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and with high-quality results
• Strong aptitude for coaching and providing on-going mentoring and guidance to team
• Ability to operate in a matrix or team environment with site, functional, and executive leadership
• Experience driving decision making by using DAI principles
• Relevant experience having led a complaints organization
• Experience leading and coaching a diverse, globally dispersed team
• Knowledge of cGMP regulations (FDA, EMEA, TUV, Health Canada) and industry standards (ISO, ICH, PICs)
• Strong verbal and written communication. Ability to communicate effectively with Senior and Executive Leadership
• Highly skilled at interacting effectively with inspectors and agency regulators
• Working knowledge of applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls)
• Ability to succinctly communicate level of risk, urgency, or impact to the business
• Practical knowledge of human factors principles and best practices
• Practical knowledge of risk assessments and their application to complaints investigation
• Ability to travel +/- 20% of time to domestic and international Amgen sites; ability to flex working hours to maximize interactions with global teams.