SUMMARY:

• Resourceful and accomplished Senior IS Leader with extensive experience in IT Project / Program Management IT Compliance, Quality Assurance (QA), Process Improvements, IT Governance and Portfolio
• Budget Management across multiple industries including Biotech/Pharma, Banking, IS Solutions. Experienced in leading cross - functional initiatives and delivering IT services globally across multiple cultures.
• Successfully delivered projects and programs in the realm of Software Application Development, IT Compliance and Quality Assurance to the tune of $15M.
• Experienced in building teams from start-up to deliver initiatives in the realm of PMO, Quality Assurance, IT Compliance, Internal Audits and continuous process improvement.
• Established Quality Management Systems, Key Compliance Policies and processes, Internal Audit processes, IT Governance frameworks and PMO processes, imbibing industry trends and adhering to industry standards like COBIT, SEI CMM, CMMi, PCMM, ISO 9000 standards for Biotech / Pharma, IT Solutions and Banking industries.
• Mentored and trained staff and consultants across Americas, EU and Asia-Pacific in Project Management, Budget Management, Program Management, Vendor Management, Quality Assurance and Compliance.
• Designed and implemented a comprehensive Quality Assurance and Project Management course for Certified Quality Analyst (CQA) program. Trained and mentored staff to obtain CQA .
• Demonstrated ability to work in a dynamic and fast-paced environment with strong inherent project/program management skills, including: managing risks, prioritizing tasks, balancing workload between multiple projects, anticipating next steps, adapting to changing situations and project scope. Capable of presenting to all levels of management, including CIO and Senior Management.
• Leadership & Staff Development
• Program & Project Management
• Vendor Management
• Portfolio & Budget Management
• IS Compliance and Regulatory
• COBIT, SEI CMM, CMMi, PCMM
• ISO 9000, Sarbanes Oxley,ITIL
• Agile, SCRUM
• Internal Auditing
• 21 CFR Part 11

PROFESSIONAL EXPERIENCE:

Confidential, CA

Senior Manager / Global Service Owner

Responsibilities:

• Led the project management activities to implement Incident, Service Requests, Change, Asset Management, Integrated System Assessment, Portfolio and Budget Management modules of ServiceNow for Sales and Marketing IS.
• Partnered with Enterprise teams to identify and implement process changes based on ServiceNow processes.
• Defined Vision, Strategy, Service Roadmap and Service Catalog for Program and Project Management Office (PMO), QA, Internal Audits, ITIL Service Management to streamline operations and achieve operational excellence.
• Partnered with IS Compliance and other IS functions to deliver an automated Operational Metrics Dashboard using Agile / SCRUM to proactively track and report on critical compliance and performance metrics to the senior management. Improved compliance by 50%. Trained and mentored 25+ associates across all regions to increase adoption of the Operational Metrics Dashboard by 70%.
• Partnered with business stakeholders, Enterprise IS Compliance team and Information Security team to establish the operating procedures / policies for the Material Approval and Compliance business function to transition from a legacy system to a cloud based solution.
• Led internal audit activities for Sales and Marketing, in partnership with IS Compliance, Corporate Audit, Regulatory, Manufacturing, internal IS Leads and Business functions to align audit schedule with critical business processes. Documented and reported audit findings all levels of management. Defined Standard Operating Procedures (SOP) to implement Corrective and Preventive Actions (CAPA) to remediate audit findings. Assured compliance to defined processes and minimized non-compliances by 40% through consistent investigations, follow-up and tracking.
• Established and managed a global technology investment portfolio, to the tune of ~$60MM.
• Tracked and managed the Departmental Operational Expenses budget to the tune of ~$20MM and contained variance within -5% to +1%.
• Implemented the Capability Architecture Planning initiative to prioritize Technology investments for Sales and Marketing. Negotiated with Sales & Marketing Business Unit and Finance as IT intermediary to prioritize 2017 technology investments for greatest transformation and value. Provided feedback to refine current immature process for implementation in 2018.

Principal IS Programmer Analyst

Confidential

Responsibilities:

• Successfully led the projects activities to implement ServiceNow and IBM Integrated Service Management tool for Incident, Change, Service Request, Release and Asset Management processes for Sales and Marketing IS.
• Successfully managed projects to the tune of $5M to deliver a centralized Operational Data Store for Sales and Marketing.
• Successfully managed and delivered End-End Quality Assurance workstreams (executed as separate projects) for drug Product Launches.
• Efficiently supported operations for Government Programs and successfully implemented controls to assure compliance with SOX Regulations. Improved compliance to SOX Regulations by more than 50%. Contributed extensively to refine the processes supporting controls and check point reviews. Defined and implemented systematic controls for SOX Compliance.
• Efficiently supported operations for Strategic Planning & Operations business area and successfully established a release management process to streamline new software releases in production.
• Represented the department at Enterprise level in IS Inspection readiness forums. Followed-up and tracked non-compliances to closure well within the specified due dates.
• Managed and delivered cross-functional workstream projects to support critical drug product launches.
• Mapped Business Critical Processes to Key IS Systems to ensure Disaster Recovery & Business Continuity Plans are in place. Completed the first ever Disaster Recovery exercise for a business-critical system supporting Strategic Planning & Operations business area.
• Led the end-end testing of computer systems to launch key products, interfacing with Commercial and Regulatory teams, supporting Healthcare Compliance, SOX, GMP, GCP processes.
• Completed a holistic audit of the Chargebacks process for Commercial Contracts to identify problem areas and presented the same to business senior management.

Confidential

Business Analyst and QA Manager

Responsibilities:

• Led the End-End Quality Assurance activities for Grant and License Management project.
• Led the End-End Quality Assurance activities to implement a product for Government Pricing calculations.

Confidential

Quality Assurance Consultant

Responsibilities:

• Led the UK operations of CMM Consultancy project for JPMorgan Chase. Executed the Strategic Assessment and Process Definition / Implementation phases to take the Investment Management Division of JPMorgan Chase to Level 2 of SEI CMM Model.

Business Analyst and QA Manager

Confidential

Responsibilities:

• Led the End-End Quality Assurance activities for a Drug Product Launch.
• Documented the As-Is and To-Be processes for a Business Process Re-engineering project for Customer Master and Alignment data management system.

Manager, QA and Process Improvement

Confidential

Responsibilities:

• Led a team of 12 to deliver quality assurance and continuous process improvement initiatives for 70+ projects across 4 centers in Chennai. Responsible for defining the vision, strategy and goals for the Quality Assurance and Internal Audit team and to assure compliance to the defined processes. Defined job responsibilities and aligned staff to successfully achieve the goals of the Quality Assurance team.
• Designed and implemented a comprehensive Quality Assurance course for Cognizant Academy’s Certified Quality Analyst (CQA) program. Trained and mentored staff to obtain CQA .