Director of Product Complaints & Surveillance

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.

Skills Required

Complaint Management, Leadership, Risk Assessment, Cgmp, Quality, Data Analytics