Sr Manager, Validation and Change Lead

Sr Manager, Validation and Change Lead

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:

The Sr Manager, Validation and Change Lead position offers a unique opportunity to join a fun, innovative engineering team within the AI & Data Science (AI&D) - organization. You’ll work on next-generation capabilities and services in Applied AI & Automation using innovative COTS products, open-source software, frameworks, tools, and cloud computing services. The role also emphasizes demonstrating these capabilities to support critical business operations and initiatives, in ensuring quality, compliance, and performance across Amgen’s Applied AI & Automation Footprint.

The role is responsible for leading and charting the course for Applied AI & Automation technology products and services team. Our team builds and transforms technology capabilities that positively impacts business outcomes.  This individual will be responsible for developing and leading a highly talented team that is built for delivering high-end and innovative technologies.  

The ideal candidate will have a proven track record of leadership in project management, Intelligent Automation, GxP Validation, Automated Testing, and Agile methodologies. Additionally, collaboration with Cross-Functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational strategic initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. 

Roles & Responsibilities:

• Maintain strategic relationships and strong communication with the leadership team about IS services and service roadmaps to ensure that all the stakeholders feel informed and engaged
• Lead and manage large, diverse teams within a matrixed organization. 
• Serve as Scrum Master for Cross-Functional Agile teams, leading sprint planning, daily stand-ups, retrospectives, and backlog grooming to ensure timely delivery of automation and AI solutions.
• Act as a servant leader by identifying and removing roadblocks, promoting Agile best practices, and fostering a culture of continuous improvement and team empowerment within the AI & Automation delivery squads.
• Define, implement, and oversee computer system validation strategies aligned with regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11) for GxP-relevant systems used across R&D, manufacturing, and quality operations.
• Collaborate with automation, IT, and quality teams to validate AI/ML-enabled systems and intelligent automation tools, ensuring their lifecycle management meets CSV and data integrity standards.
• Serve as CSV subject matter expert (SME) during internal and external audits or health authority inspections, providing defensible validation documentation and training Cross-Functional stakeholders.
• Collaborate with geographically dispersed teams, including those in the US and other international locations. 
• Attract and recruit top talent as part of an extensive AI & Technology organization to be hired within India. 
• Responsible for managing, growing, and developing the Amgen Technology team in India, ensuring global ways of working are imbedded in the local organization
• Understand the decision-making process, workflows, and business and information needs of business partners and stakeholders
• Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through 'test & learn' activities
• Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as an escalation point and facilitating communication when service commitments are not met
• Ensure communication of key performance metrics and analysis of unmet needs
• Participate in stakeholder and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery
• Facilitate best practice sharing, ensuring ongoing alignment with the Technology & Digital strategy
• Oversee operating budgets and product team budgets, ensuring regular review of actuals and latest estimates, managing according to agreed governance

Basic Qualifications and Experience:

• Master’s degree with 8 - 10 years of experience in Business, Engineering, IT or related field  OR
• Bachelor’s degree with 10 - 14 years of experience in Business, Engineering, IT or related field  OR

Functional Skills:

Must-Have Skills:

• Strong knowledge of Agile methodologies, CSV Validation and Automated Testing. 
• Exceptional collaboration, communication and interpersonal skills to effectively manage stakeholder relationships and build new partnerships.
• Have strong business acumen. Can demonstrate deep understanding business processes in a biotechnology environment.
• Familiarity with Intelligent Automation with experience in automations tools like UiPath & Power Automate, Process Intelligence tools like Celonis, DocuSign and GenAI Tools/LLMs. 
• Proven ability to lead multidisciplinary teams including analysts, engineers, and architects in a matrixed and agile environment. 

Good-to-Have Skills:

• Experience in a leadership role within a pharmaceutical or technology organization
• Extensive experience in software development lifecycle. 
• Experience using and adoption of Scaled Agile Framework (SAFe) 
• Strong analytic/critical-thinking and decision-making abilities.  
• Ability to work effectively in a fast-paced, dynamic environment.
• Established business partnerships and IS governance practices involving senior business stakeholders
• Broad working knowledge of key AI, Intelligent Automation, IS and Business domains 
• Familiarity with regulations (e.g., FDA 21 CFR Part 11, EU Annex 11) and risk-based validation

Professional Certifications:

• Computer System Validation Professional (CSV) Certification (preferred)
• Certified ScrumMaster (CSM) or SAFe Scrum Master (SSM) (preferred)
• Project Management Professional (PMP) (preferred)

Soft Skills:

• Excellent leadership and team management skills. 
• Strong transformation and change management experience. 
• Exceptional collaboration and communication skills. 
• 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.
• Excellent analytical and troubleshooting skills
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams
• Regulatory Writing: Ability to write clear, audit-ready documentation and validation reports.
• Leadership: Leading validation teams, mentoring junior staff, driving validation strategy.
• Analytical Thinking: Ability to troubleshoot issues and apply critical thinking to problem-solving.
• Attention to Detail: High standards for compliance, documentation accuracy, and traceability.

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 an accommodation.