Director of Product Complaints

Job Description

- 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.

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