Amgen Careers – Executive Director Quality

Website Amgen

Job Description:

The Executive Director Quality is responsible for leading the strategy and execution of Quality oversight for the global complaint business process and management system at Amgen. This role will report to the Vice President, Final Product Quality and Surveillance and assures complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. The position Interfaces directly with agencies during inspections and provides response to agency requests regarding the complaints process and leads the team through the development of requirements and ensures procedures are in place for the complaint management system. He/She will work closely with global regulatory and safety leadership to assure complaints business process is adapted to emerging trends or new requirements in regulations while working in close partnership with internal Amgen leadership and executive management beyond Operations to ensure successful issues resolution and continuous improvement.

Job Responsibilities:

  • Responsible to provide oversight of training and ensure continued effectiveness for call center staff
  • Oversight of global complaints business process management and continuous improvement, including setting the global strategy for complaints management
  • Establish complaint triggers and analyze trends looking across products and delivery systems
  • Manage data sources used for trending, provide necessary data to technical teams for advanced analysis
  • Direct interaction with health and regulatory authorities during inspections, speaking on behalf of Amgen
  • Applies in-depth knowledge and subject matter expertise to determine the steps necessary to advance the quality system in order to address complaint causes
  • Oversight of internal lab operations for investigations of return complaint samples
  • Leverages expertise and effectively engages with technical functions to translate risk assessments into complaint codes and decision trees and ensure continual alignment with regulatory filings
  • Provides accurate and robust surveillance information that meets global health authorities and Amgen requirements
  • Assure proper program design is used to assign site assessments for complaints
  • Maintains oversight of complaints throughout the life cycle from intake, processing, and through closure
  • Ensure there is alignment between linked product complaint and adverse events and safety investigations

Job Requirements:

  • Makes risk-based decisions based on Amgen First and decision-making processes that reflect Quality beyond compliance
  • Ability to remain calm under duress or in stressful situations
  • Ability to understand details, and also flex to understand and communicate strategic intent
  • Problem solving, trouble shooting, and communication skills
  • Doctorate degree & 6 years of Quality experience OR
  • Deep and broad understanding of Quality including batch release, complaints, change control, risk management, etc
  • Ability to articulate issues to executive leadership
  • Advanced degree in Biology, Pharmaceutics, Biotechnology, Engineering, Physics or related discipline

Qualification & Experience:

  • Experience creating an environment that promotes growth (develops leaders) and provides the tools to develop the next generation of leaders
  • Master’s degree & 10 years of Quality experience OR
  • 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
  • 15+ years of experience within the pharmaceutical/biotechnology industry
  • Bachelor’s degree & 12 years of Quality experience AND
  • Experience with leadership in various quality functions

Job Details:

Company: Amgen

Vacancy Type: Full Time

Job Functions: General Business

Job Location: Thousand Oaks, CA, US

Application Deadline: N/A

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