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Amgen

#WeareBiotech

Director, Precision Medicine and Diagnostics Quality

DirectorDirectorFull TimeRemoteLeadTeam 10,001+Since 1980H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

2 days ago

Salary

$198.5K - $229.9K / year

Seniority

Lead

Postgraduate Degree4 yrs expExperience acceptedEnglish

Job Description

• 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

Job 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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