Director of Product Complaints & Surveillance

What you will do

Lets do this. Lets change the world. In this vital role you will lead a global quality complaints team, maintaining accountability for its daily operations. You will ensure complaint processes and systems remain compliant through quality operating standards and procedures to current, emerging internal and external requirements. You will work with key internal stakeholders to enable issues resolution and continuous improvement. You will work closely with Amgen global regulatory and safety teams to ensure complaints business processes are adapted to emerging trends or new requirements in regulations. You will ensure that there is an adequate team of qualified personnel who possess a combination of education, experience, and training to perform the work in accordance with requirements and specifications.

As a Director Quality Assurance, Product Complaint and Surveillance you will report to the Executive Director, Quality Head and:

• 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

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

Doctorate degree and 8 years of Quality experienceOR

Masters degree and 15 years of Quality experience OR

Bachelors degree and 20 years of Quality experience AND

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.