Senior Delivery Assurance Associate (GXP, CSV)

The Senior Delivery Assurance Associate will serve as a key member of our Delivery Assurance Group, responsible for instantiating delivery assurance with experts who actively partner with delivery teams to bring innovation and ensure consistent adoption of technology delivery best practices across ZS. The role involves working closely with various stakeholders, defining process, enabling process implementation analyzing process compliance ensuing CMMI maturity and compliance, and providing input into the development and maintenance of DAG and risk scores. The candidate will also assist in the management of DAG assets and contribute to various delivery assurance related initiatives and special projects.

What You'll Do:

• Perform periodic project audits / reviews for the project delivery process based on CMMI (Capability Maturity Model Integration) process areas and report non compliances, best practices followed
• Highlight potential delivery risks and compliance issues for the project milestones
• Participate in project milestone release readiness review and provide sign offs
• Assist in QRM cadence planning and work closely with QRM Leads ensuring effective risk management and mitigation throughout lifecycle of projects
• Conduct trainings on QMS process assets and awareness on best practices
• Maintain and ensure project process maturity (CMMI Level 3) adherence for ensuring Capability Maturity Model Integration (CMMI) v2.0 Development & Services appraisal and accreditation process
• Guides and train project teams on Project Management and Delivery Excellence best practices and supporting project management tools such as Atlassian JIRA, Confluence, Microsoft Enterprise Project Management (EPM) & BT Estimation tool
• As a DAG partner work with project teams to bring in innovation ensure consistent adoption of technology delivery best practices
• Showcase expertise on Software Quality Management framework such as CMMI Development, CMMI Services and focus on performance and continuous improvement at project as well as organization level
• Enhance Delivery and Operations maturity through close engagement and planned intervention across all project phases
• Coaching and training the project team members on focus areas such as Agile project delivery methodology and supporting tool stack
• Definition and regular enhancement of enterprise level Quality Management System aka Enterprise Delivery Framework (EDF) supporting Development (Waterfall, Agile) as well as Operations projects (Services delivery methodology).
• Strong understanding of GxP regulations and industry standards.
• Serve as the point of contact for regulatory agencies and manage audits related to GxP compliance. Experience with software validation tools and methodologies.
• Develop and maintain policies and procedures that support compliance with GxP,, and other relevant regulatory frameworks. Proficiency in preparing validation documentation.
• Develop and deliver training programs on GxP compliance, and other regulatory requirements to ensure employees are aware of and adhere to relevant guidelines

What You'll Bring:

• Bachelor's degree in IT or relevant field with a strong academic record.
• A minimum of 5 years of experience in Delivery Assurance and Quality Management ; Minimum of 3-5 years of experience in Computer System Validation (CSV) within a GxP-regulated environment (pharmaceutical, biotech, or healthcare preferred).
• Knowledge and experience in Software Quality Management & Software Quality Standards.
• Familiarity with regulatory requirements (FDA, EMA, 21 CFR Part 11, GAMP 5, EU Annex 11, etc.).
• Experience with risk-based validation methodologies.
• Through understanding and implementation experience of CMMi 2.0 framework for Dev & Services
• Proficiency in MS Office, including Word, Excel, and PowerPoint.
• Experience with Project management tools (e.g., Atlassian JIRA, Confluence, MS project ) and Quality Assurance tools
• CMMi implementation experience (Maturity level 3 at minimum/ High maturity implementation experience preferred )
• Familiarity with Pharma compliance and regulations - CFR Part 11/GXP
• Strong communication skills, both written and verbal, for reporting and interacting with stakeholders.
• Ability to work independently and as part of a team
• Willingness to adapt to evolving industry standards and technologies
• Ability to manage a wide variety of tasks and meet deadlines, and reliability/dependability
• Proven ability to work creatively and analytically in a problem-solving environment