Software Quality & Validation Lead

• Roles & Responsibilities:

• Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications.
• Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports.
• Ensure validation strategies meet regulatory requirements and company standards.
• Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents.
• Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards.
• Contribute to test automation scripting, framework maintenance, and CI/CD integration.
• Implement automated test suites across various layers including data pipelines, APIs, and semantic layers.
• Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis.
• Collaborate with multi-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines.
• Supervise the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan.
• Ensure timely and effective completion of all validation activities in line with project objectives and schedules.
• Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management.
• Find opportunities for process improvements in validation activities.
• Stay ahead of on new technologies, validation trends, and industry best practices to improve validation efficiencies.
• Collaborate and communicate effectively with the product teams.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Master s degree with 4-6 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience OR
• Bachelor s degree with 6 - 8 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience OR
• Diploma with 10 - 12 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience

Preferred Qualifications:

• Must-Have Skills:

  5+ years of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc).
• 8-10 Years overall experience in Testing & Validation Projects
• 3 to 5 years overall experience in QA & Test Automation is expected.
• Experience leading software validation projects.
• Proficiency in developing and implementing validation protocols (IQ, OQ, PQ), reports, and related documentation.
• Hands-on experience implementing and analyzing automated test suites
• Familiarity with computer system validation and software validation is a plus.
• Strong problem-solving and analytical skills.
• Excellent communication and teamwork skills.

Good-to-Have Skills:

• Experience with automated and computer-controlled systems validation (21 CFR Part 11)

• Soft Skills:

• Excellent analytical and troubleshooting skills.
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation.
• Ability to handle multiple priorities successfully.
• Team-oriented, with a focus on achieving team goals.
• Ability to learn quickly, be organized and detail oriented.
• Strong presentation and public speaking skills.