Director, Precision Medicine and Diagnostics Quality Job at Amgen

Job Description

In this vital role you will report to the Executive Director, Precision Medicine/Dx and R&D Supplier Quality. The Director, Precision Medicine/Dx provides leadership to a professional quality team who support IVDR, ICH E6 (R3), GCP, and other relevant regulatory requirements and standards related to In-Vitro Diagnostics (IVD), including Digital Diagnostics, Companion Diagnostics (CDx), and Precision Medicine applications in clinical development. This role is responsible for the development and implementation of an end to end, proactive and risk-based Quality Assurance strategy for Precision Medicine and Diagnostics, including third-party collaborations.

Job Responsibility

Develop collaborative partnerships with Research and Development (R&D) Leadership to define the state of quality and potential areas of quality risk exposure for Amgen’s In-Vitro Diagnostic use within Precision Medicine studies
Develop innovative methods for improving the quality oversight for Amgen’s IVD and Precision Medicine programs, including oversight of partners, suppliers, and service providers that are critical to Amgen’s efforts to reach the right patients at the right time and dosage
Provide quality leadership in a matrixed environment and ensure that Amgen’s R&D efforts, including partnerships and third parties, are aligned to industry best practices and all regulations
Develop and implement IVD quality management strategies (including risk-based regulatory approaches) that ensure compliance to an evolving and complex IVD regulatory landscape, particularly in the EU and US
Partner with leadership teams and key stakeholders to develop/ monitor metrics (KQI, KPI leading and lagging) for critical to quality IVD and Precision Medicine processes that aim to identify risks and areas needing improvement at key oversight forums (e.g. management reviews)
Coordinate and collaborate with clinical trial teams to ensure that all respective critical to quality components are incorporated into clinical trial design, execution and support of regulatory filings
Maintain up-to-date knowledge of IVD regulations and applicable guidance
Provide risk-based quality assurance and oversight for IVD/ Precision Medicine activities (e.g., auditing, deviation management and inspection management)
Ensure that all applicable integrated procedures (e.g., acquired assets) are fit for purpose and aligned to Amgen’s standards
Oversee the management of IVD-related QMS elements related to business procedures including the development and execution of the process and audit program, and the support of Inspections by Health Authorities or notified bodies
Develop and lead a global team of quality professionals to support advancement of Amgen’s Precision Medicine pipeline and to continuously improve processes

Requirements

Doctorate degree and 4 years of Quality Management, Quality Assurance, or other relevant experience
Master’s degree and 8 years of Quality Management, Quality Assurance, or other relevant experience
Bachelor’s degree and 10 years of Quality Management, Quality Assurance, or other relevant experience
At least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Nice to have

7 years of managerial experience directly leading people in a multi-tiered organization and/or leadership experience leading teams, projects, programs or directing the allocation of resources
7 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry developing and implementing risk-based quality oversight/ management, and experience with medical device development and quality management
Oversight and implementation of Quality Management Systems, including use of electronic QMS such as Veeva
Proficiency in the practical application of AI-enabled tools to enhance day-to-day productivity and business outcomes, including the ability to synthesize information, generate insights, streamline workflows, and apply appropriate judgment
Deep knowledge of QMS requirements related to IVD, medical device regulations, and Precision Medicine
implementation of technology to improve knowledge management across a diverse R&D environment
Thorough understanding of Biotech/pharmaceutical Research activities and Global Regulations
Experience with compliance to all GxP requirements including the oversight of third-party vendors, suppliers, and partners
Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format
Strong analytical, critical-thinking, and decision-making abilities, including development and implementation of Analytics methods and technology in order to enable signal detection and quality improvement
People leadership and managerial expertise, and an ability to build a high performing team
Excellent verbal and written communication skills, including strong business writing abilities and active listening
Capability to understand and articulate technical concepts and literature in spoken and written English

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

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Director, Precision Medicine and Diagnostics Quality

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