Director, Precision Medicine and Diagnostics Quality
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Job Description
Director leading Quality Assurance strategy for Precision Medicine and Diagnostics at Amgen. Collaborating with R&D teams and ensuring compliance with regulatory standards.
Responsibilities:
- Report to the Executive Director, Precision Medicine/Dx and R&D Supplier Quality
- Provide leadership to a professional quality team
- Develop and implement an end to end, proactive and risk-based Quality Assurance strategy for Precision Medicine and Diagnostics
- Ensure compliance to an evolving and complex IVD regulatory landscape
- Develop collaborative partnerships with R&D Leadership to define the state of quality and potential areas of quality risk exposure
- Coordinate and collaborate with clinical trial teams to incorporate all respective critical to quality components into clinical trial design
- Maintain up-to-date knowledge of IVD regulations and applicable guidance
- Oversee the management of IVD-related QMS elements related to business procedures
Requirements:
- Doctorate degree and 4 years of Quality Management, Quality Assurance, or other relevant experience OR Master’s degree and 8 years of Quality Management, Quality Assurance, or other relevant experience OR 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
- 7 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry
- 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
- Deep knowledge of QMS requirements related to IVD, medical device regulations, and Precision Medicine
- Strong analytical, critical-thinking, and decision-making abilities
- Excellent verbal and written communication skills, including strong business writing abilities and active listening.
Benefits:
- 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
- flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible.
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