Software Quality & Validation Lead - Remote

Overview

As a Software Quality & Validation Lead at Amgen, you will oversee and handle validation activities for data platforms and custom-built solutions, ensuring compliance and quality in the development of innovative medicines.

In Short

• Lead validation activities for data products and software applications.
• Develop and approve validation documentation such as Validation Plans and Protocols.
• Ensure compliance with regulatory requirements and company standards.
• Contribute to test automation scripting and CI/CD integration.
• Collaborate with cross-functional teams to meet project deadlines.
• Supervise validation activities and align with project plans.
• Identify opportunities for process improvements in validation.
• Stay updated on validation trends and best practices.
• Communicate effectively with product teams.
• Make a lasting impact on the lives of patients through quality assurance.

Requirements

• Master’s degree with 4-6 years of relevant experience, or equivalent qualifications.
• 5+ years of experience in validation in a GMP-regulated environment.
• Experience leading software validation projects.
• Proficiency in developing validation protocols and documentation.
• Hands-on experience in automated test suites.
• Strong problem-solving and analytical skills.
• Excellent communication and teamwork skills.
• Ability to work effectively with global, virtual teams.
• Strong initiative and self-motivation.
• Detail-oriented with strong organizational skills.

Benefits

• Competitive and comprehensive Total Rewards Plans.
• Support for professional and personal growth.
• Collaborative culture fostering innovation.
• Opportunities to make a lasting impact on patient lives.
• Inclusive environment promoting diversity and respect.