Manager Information Systems – Validation Lead (Veeva Vault)

Role Name: Manager Information Systems – Validation Lead (Veeva Vault)

Job Posting Title: Manager Information Systems

Workday Job Profile: Manager Information Systems – Validation Lead (Veeva Vault)

Department Name: Digital, Technology and Innovation

Role GCF: 5A

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role Description:

This role involves working closely with Veeva Vault Engineering Team and Business Stakeholder to ensure that validation strategy and deliverables for Veeva Vault systems.  This role will also be involved in release management and compliance with the Veeva Vault system. The successful candidate will work on a small team and support continuous improvements and automation withtin the Veeva Vault system. This position combines technical expertise, validation experience, and a strong understanding of Pharma regulatory requirements.  

The role also leverages domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated.   

Roles & Responsibilities:

• Collaborate with System Architects and Product owners to manage Validation strategy and Deliverable for the GxP applications.  

• Develop and manage test cases, protocols, and validation documentation within the Veeva VM Testing Vault. 

• Execute test scripts to ensure system compliance with regulatory requirements and organizational standards. 

• Identify, document, and track defects during the testing process. 

• Collaborate with development teams to resolve defects and validate fixes. 

• Ensure all testing and validation activities comply with GxP, FDA 21 CFR Part 11, and other regulatory standards. 

• Maintain comprehensive audit trails and validation documentation to support regulatory inspections. 

• Configure and optimize workflows within the VM Testing Vault to streamline test management and approval processes. 

• Partner with quality assurance, IT, and business teams to ensure alignment on validation objectives and testing requirements. 

• Act as a liaison between technical teams and stakeholders to ensure system requirements are met. 

• Provide training to end-users on Veeva VM Testing Vault functionalities and best practices. 

• Offer ongoing support to ensure effective use of the platform. 

• Generate reports and dashboards to monitor testing progress, defect trends, and validation status. 

Basic Qualifications and Experience:

• Doctorate Degree OR
• Master’s degree with 4 - 6 years of experience in Computer Science, IT or related field  OR
• Bachelor’s degree with 6 - 8 years of experience in Computer Science, IT or related field OR
• Diploma with 10 - 12 years of experience in Computer Science, IT or related field
• Bachelor’s degree with 8 - 10 years of experience in Computer Science, IT or related field  OR
• Diploma with 12 - 14 years of experience in Computer Science, IT or related field

Functional Skills:

Must-Have Skills:

• Solid understanding of GxP regulations, specifically 21 CFR Part 11. 

• Expertise in defining and executing validation strategies aligned with regulatory requirements. 

• Experience in creating and executing validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)) 

• Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity 

• Familiarity with GxP Validation management tools such as ALM, Veeva Vault Management etc.    

Good-to-Have Skills:

• Proficiency in automation tools, data systems, and validation software (Application Lifecycle Management and/or  Veeva Vault Validation Management) 

• Experience of DevOps, Continuous Integration and Continuous Delivery methodology 

• Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies 

Professional Certifications (please mention if the certification is preferred or mandatory for the role):

• Veeva Vault Platform Administrator (preferred)
• SAFe – DevOps Practitioner (preferred)
• SAFe for teams (preferred)

Soft Skills:

• Able to work under minimal supervision  

• Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work  

• Excellent analytical and gap/fit assessment skills  

• Strong verbal and written communication skills  

• Ability to work effectively with global, virtual teams  

• High degree of initiative and self-motivation  

• Ability to manage multiple priorities successfully  

• Team-oriented, with a focus on achieving team goals  

• Strong presentation and public speaking skills  

Shift Information:

This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.