Senior Specialist

As a Senior Specialist in Quality Assurance within the IT Quality organization, you hold a leadership role responsible for providing quality oversight and guidance on risk-based validation and Computer Software Assurance (CSA) for GxP computerized systems and to support the program management activities including managing the strategic goals, key performance indicators (KPIs), analyzing data to identify areas for improvement, implementing changes to optimize operations, and ensuring teams are performing at their highest potential to achieve organizational objectives;they often collaborate with other departments to drive company-wide success.

Project/Program management:

• Work with leaders to define success measures & metrics. Track defined metrics to measure success of program features, help to analyze results.
• Identifying inefficiencies in operational processes and implementing improvements to streamline workflows and increase productivity.
• Developing and executing long-term strategies aligned with company goals, including identifying growth opportunities and potential risks.
• Coaching and mentoring Overall Quality team, fostering a high-performing team culture, and providing ongoing performance feedback.
• Presenting performance updates to senior leadership, communicating strategic initiatives to teams, and providing clear direction.
• Prepare and review analytics to provide access to the effectively of operational plans.

Project Focus Areas

• Proficient with CSA (Computer Software Assurance) methodology to focus validation on high-risk areas and reduce redundant testing for GxP Systems.
• Lead the complete lifecycle of GxP system validation: risk assessment, Business requirements, configuration specifications, traceability matrix, IQ/OQ/PQ protocols, and periodic review.
• Lead all aspects of qualification and revalidation efforts for ERP (e.g., SAP), LIMS, ELN, CDS, QMS, MES, and cloud-hosted GxP platforms.
• Lead qualification and validation deliverables for SAP ERP systems (including S4/HANA), ensuring adherence to industry standards and regulatory requirements such as GxP and SOX.
• Proficient in tools and systems such as ServiceNow, Jira, Confluence, HP ALM, Veeva Vault, Track wise.
• Ability to manage /execute/review the risk assessments performed for the GxP Computer systems and provide guidance on the overall process as SME on internal procedures and external regulatory requirements.

• Implement robust change control processes aligned with validation maintenance and ensure audit trail and deviation management integrity.

• Partner with cross-functional teams to drive AI readiness and build competencies within the IT Quality organization, focusing on the integration of AI into existing compliance systems while ensuring data integrity and security.

• Strong understanding of periodic reviews and audit trail assessments for computer system validations, ensuring compliance, system integrity, and risk identification.
• Manages supplier relationships for software applications, including vendor selection and qualification, contract management, and ensuring timely and quality software delivery.
• Oversees the Quality Management System (QMS) for computerized systems, ensuring compliance, documentation, and continuous process improvement.

Responsibilities

• Analytical Skills: Strong ability to interpret data, identify trends, and draw actionable insights.
• Strategic Thinking: Capability to develop and implement long-term strategies aligned with business objectives.
• Leadership Skills: Effective communication, team building, and ability to motivate and inspire others.
• Project Management: Proven ability to lead complex projects from initiation to completion.
• Assess the regulatory risks associated with development and implementation of new/ongoing computerized systems ensuring the quality and adherence to GxP Principals and regulatory requirements.
• Collaborate effectively with Business owner, System /Technology leads and other functions to ensure the delivery of quality outcomes.
• Involve in future-focused strategy in AI and emerging technologies readiness, evaluating regulatory requirements and developments to ensure Amgen QMS is fit for purpose.
• Strengthen external collaborations to get Industry benchmarking and to get more insights on the new regulatory requirements and Health Authority expectations for the computerized systems, proactively identify them and get them adapted into the internal processes and systems.
• Effective inspection readiness leading to % reduction in audit findings related to computerized systems.
• Ensure that appropriate policies, SOPs and documentation are in place to support validation practices according to regulatory requirements and applicable industry guidance documents.
• Strong project management skills with experience supervising quality professionals working with cross functional and global stakeholders across multiple time zones.
• Assess and guide the team in performing Periodic Review of Systems and Audit Trail Reviews.
• Manage change controls, validation and review and approval of validation deliverables per procedure (e.g. Validation Plan, Test Strategy, Validation Summary Report, etc.).
• Supplier Management activities for Computerized Systems and other validation disciplines/processes (e.g. Equipment, Analytical, etc.)
• Support, review and approval of failure investigations & CAPA as a Quality Contact pertaining to Computer Systems.
• Participation and support of regulatory inspections as needed.

Basic Qualification

• Masters degree with a minimum of 10 years in Quality Experience including mandatory experience with Project/Program management.
• Leadership skills and the ability to oversee multiple projects simultaneously
• Ability to successfully manage workload to timelines
• Familiarity with advance project management tools
• Ability to operate in a matrixed or team environment with site, functional, and executive leadership
• Experience in driving decision making by using DAI principles
• Understanding of quality and industry requirements/expectations of a QMS
• Understanding of the applicable manufacturing/testing processes (i.e., API, Drug
• Substance, Drug Product, Packaging, Device manufacturing processes)
• Ability to negotiate a strategic position after taking feedback from multiple sources
• Excellent communication, negotiation, consulting/facilitation, and interpersonal skills.

Preferred skills

• Demonstrated experience (3-5 years) training others in activities outline above.
• Establish/Improve and actively participate in training curriculum and delivery of this material.
• Sophisticated understanding of ITIL, Agile methodologies, DevOps, CI/CD and cloud- native architectures.
• Process steward to create/perform impact assessment on the change revision to the SOPs, WI, Job Aids and any other process documents related to IT Quality as required by internal /external regulatory requirements.
• Define and track automation KPIs, quality metrics, and build dashboards in collaboration with peers.
• Proficient with Smartsheet other BI Platforms , building dashboards using power BI, Tableau ,Spotfire.

The following are some examples of tasks for the position

• Strong understanding of Risks Assessment and how to apply risk-based decision making to all processes related to IT systems.
• Determine and establish requirements for system/equipment or processes.
• Act as a reviewer and approver for SOPs, validation deliverables and /or QMS related records (Deviation/CAPA).
• Review and Approve System Life Cycle Documents (i.e. Validation deliverables).
• Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
• Leverages qualitative insights and quantitative research, analyzes trending data, and utilizes forecasting models and advanced analytical tools to drive continuous improvement in IT quality and performance.
• Anticipates and prevents potential problems.
• Independently develop solutions that are thorough, practical and consistent with functional objectives.
• Provides management review updates on quality metrics, analyzing data and recommending improvements to enhance quality standards.
• Bring topics and critical decisions to managements attention and initiate and enforce necessary improvements and corrections to established systems and processes compliance.