Director, Precision Medicine and Diagnostics Quality

The role involves leading quality assurance strategies for In-Vitro Diagnostics and Precision Medicine applications in clinical development, supporting regulatory compliance and continuous improvement.

Location: Washington D.C., District of Columbia, United States

Responsibilities

• Develop collaborative partnerships with R&D leadership to define quality and risk exposure for In-Vitro Diagnostic use within Precision Medicine studies.
• Develop innovative methods for improving quality oversight for IVD and Precision Medicine programs, including oversight of partners, suppliers, and service providers.
• Provide quality leadership in a matrixed environment ensuring alignment with industry best practices and regulations.
• Develop and implement IVD quality management strategies, including risk-based regulatory approaches, for compliance in the EU and US.
• Partner with leadership to develop and monitor metrics for critical quality processes to identify risks and improvement areas.
• Coordinate with clinical trial teams to incorporate quality components into trial design and regulatory filings.
• Maintain knowledge of IVD regulations and guidance, monitor new regulations, and communicate impacts.
• Provide risk-based quality assurance and oversight for IVD/Precision Medicine activities, including audits and inspections.
• Ensure procedures are fit for purpose and aligned with standards.
• Oversee management of IVD-related QMS elements, including process and audit programs.
• Develop and lead a global team of quality professionals supporting the Precision Medicine pipeline.

Requirements

• Doctorate degree with 4+ years of relevant experience OR
• Master’s degree with 8+ years of relevant experience OR
• Bachelor’s degree with 10+ years of relevant experience.
• At least 4 years of experience managing people or leading teams, projects, or programs.

Benefits

• Competitive salary and total rewards plan including health and welfare plans, retirement and savings plan, bonus programs, stock-based incentives, time-off plans, and flexible work models.

Additional Information

• The role can be hybrid, fully remote, or flex-worker.
• Application deadline is open until a suitable candidate is found.
• Sponsorship is not guaranteed.
• Amgen fosters an inclusive environment and is an Equal Opportunity employer.