Amgen
Biotechnology
SeniorValidationManagerInformationSystems
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Validation Manager Information Systems at Amgen. Skills: Validation strategy, People management, GxP regulations. Establish validation strategy. Act as subject matter expert”
What You'll Achieve.
Ensure compliance with regulatory standards; Foster a culture of quality and continuous improvement; Deliver innovative and robust technology solutions; Support biostatistical study design and analysis; Maintain rigorous validation standards; Ensure seamless integration; Ensure operational excellence; Ensure compliance across all deliverables; Champion validation requirements; Drive transformation; Support key organizational strategic initiatives; Uphold high-quality validation standards; Deliver results within a matrixed organizational structure; Ensure alignment with organizational goals and regulatory standards; Enhance quality assurance activities; Optimize validation procedures; Enhance operational efficiency; Empower validation engineers; Ensure seamless integration of validation requirements; Ensure timely resolution of issues; Adherence to regulatory guidelines; Improve activities being measured; Ensure that delivery matches commitments; Facilitate communication when service commitments are not met; Ensure successful delivery; Ensure that all stakeholders feel informed and engaged; Ensure ongoing alignment with strategy, compliance, and regulatory requirements; Ensure ongoing alignment with the Technology & Digital strategy; Managing according to agreed governance; Ensure alignment of Technology service plans across organization; Remain accountable for ensuring overall organizational compliance to quality/compliance requirements
Industry & Context.
Analytical and troubleshooting skills
Work a later shift, May be assigned a second or third shift schedule, Willing and able to work during evening or night shifts
What They're Looking For.
Must Have
Doctorate Degree and 2 years of experience in Life Sciences Information Technology Management or related field, Master’s degree with 8 - 10 years of experience in Life Sciences Information Technology Management or related field, Bachelor’s degree with 10 - 14 years of experience in Life Sciences Information Technology Management or related field, Diploma with 14 - 18 years of experience in Life Sciences Information Technology Management or related field, Solid understanding of GxP regulations, specifically 21 CFR Part 11, Expertise in defining and executing validation strategies aligned with regulatory requirements, Experience in people management and leading matrixed teams, and passion for mentorship, culture and fostering the development of talent, Demonstrated experience in managing technology teams and innovations with a track record of successful innovation, Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment, Exceptional collaboration, communication and interpersonal skills to effectively manage stakeholder relationships and build new partnerships
Nice to Have
Solid understanding of biostatistical analysis methods, clinical pharmacology, and clinical pharmacokinetic analyses, Experience in a leadership role within a pharmaceutical or technology organization, Experience using and adoption of Scaled Agile Framework (SAFe), Ability to work effectively in a fast-paced, dynamic environment, Established business partnerships and IS governance practices involving senior business stakeholders, Proficiency in automation tools, data systems, and validation software (Application Lifecycle Management and/or Veeva Vault Validation Management)
What You'll Do.
Establish validation strategy
Act as subject matter expert
Oversee quality assurance activities
Mentor validation team members
Lead process improvement initiatives
Develop and manage validation engineers
Collaborate with global teams
Monitor validation documentation
Foster culture of collaboration
Attract and recruit talent
Collaborate with geographically dispersed teams
Understand business needs
Improve measured activities
Ensure communication of metrics
Work with Product Owners
Participate in leadership meetings
Maintain strategic relationships
Follow global standards
Ensure alignment with strategy
Facilitate best practice sharing
Oversee operating budgets
Ensure alignment of service plans
Provide education to partners
Remain accountable for compliance
How You'll Work.
Team & Collaboration
Collaborate extensively with cross-functional and global teams; Collaborate with geographically dispersed teams, including those in the US and other international locations; Work with Product Owners, Service Owners and/or delivery teams; Participate in stakeholder and other leadership meetings, working with other parts of the organization, and functional groups; Maintain strategic relationships and communication with the leadership team; Ability to work effectively with global, virtual teams
Communication Scope
Exceptional collaboration, communication and interpersonal skills; verbal and written communication skills; Exceptional collaboration and communication skills
Process & Methodology
Manage multiple activities and priorities, Manage technology teams, Manage a skilled team of validation engineers, Manage stakeholder relationships, Manage multiple priorities successfully, Oversee operating budgets and product team budgets
Full Job Description
## **Career Category** Information Systems ## ## **Job Description** ** _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_** ** _Clinical Data Hub_** Amgen’s Clinical Data Hub (CDH) is an Information Technology product team chartered to identify, design and implement technology that powers Amgen’s end‑to‑end drug development lifecycle. We are at an inflection point, accelerating through rapid, AI‑driven modernization to build clinical data products that enable both drug regulatory submissions and drug discovery and development. If you’re passionate about turning complex clinical data into resilient, scalable products that help speed life‑changing medicines to patients worldwide, this is a once‑in‑a‑decade opportunity to do your career‑best work on a global stage. ** _Role Description:_** This role is pivotal in shaping and driving the overall validation strategy within the Clinical Design and Analysis technology services group. This role will serve as the subject matter expert for validation processes, ensuring compliance with regulatory standards and best practices throughout the technology lifecycle. By mentoring and guiding validation team members, this individual will foster a culture of quality and continuous improvement as the group builds and transforms technology capabilities that directly impact business outcomes. Their leadership will be instrumental in developing and managing a highly skilled team of validation engineers, empowering them to deliver innovative and robust technology solutions that support biostatistical study design and analysis,
Applying for this Senior Validation Manager Information Systems role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Amgen?
Real rants from real employees. Read before you apply.