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Akshay Kumar
Akshay Kumar
Senior Manager in Governance, Risk & Control
Akshay Kumar is a Senior Manager in Governance, Risk & Control with over 14 years of experience in Quality Systems, Regulatory Compliance, GxP Validation, Risk Management, and Data Integrity. He leads global cross-functional teams in large-scale quality transformations, risk-based validation programs, and audit readiness initiatives across pharmaceutical and biotech environments. Skilled in developing governance frameworks, optimizing quality processes, and ensuring alignment with FDA, EMA, and ICH guidelines, Akshay consistently delivers high-impact compliance solutions that strengthen organizational oversight and regulatory readiness. His expertise spans QMS oversight, CAPA management, vendor audits, computerized system validation, and digital quality system implementations such as Veeva and TrackWise.
FORMERLY AT
Biogen, Inc.
LOCATION
Banglore,India
AVAILABILITY
Full Time
Skills
Asana
Audit & CAPA Systems
Audit Systems
Change Management Systems
CSV Documentation Tools
Data Integrity Tools
DocCompliance
eeva QMSHP ALM
ERP Systems
HP ALM
LMS
MS Office Suite
MS Visio
ServiceNow
Teams
+5 More
Work Experience
Sr. Manager – Governance, Risk & Control
Biogen, Inc.
2021 – Present
- Leads Medical Affairs risk management programs including risk assessments, control analyses, audit readiness, and process improvement initiatives.
- Collaborates with Corporate Compliance, Global QA, and Internal Audit to maintain governance alignment.
- Oversees development of process documentation, training curricula, and monitoring tools for adherence and escalations.
- Drives cross-functional continuous improvement through RCA and effectiveness checks.
TECHNOLOGIES
Veeva QMS, ServiceNow, TrackWise, Audit & CAPA Systems, LMS, DocCompliance, MS Office Suite, MS Visio, Teams, WebEx, Zoom
Quality Manager
Vertex Pharmaceuticals, Inc.
Jan 2017 – Jan 2021
- Led Data Integrity initiatives and risk governance efforts across multiple therapeutic pipelines.
- Directed risk-based validation strategy, testing, and go-live readiness for high-risk GxP systems.
- Reviewed and approved CSV deliverables, change controls, CAPAs, and SOPs.
- Supported supplier qualifications and vendor audits. Played a key role in Veeva eQMS and RIM implementation.
TECHNOLOGIES
Veeva eQMS, Veeva RIM, TrackWise, Audit Systems, Data Integrity Tools, ServiceNow, HP ALM, Asana
Validation Analyst – ERP Risk & Compliance
Pfizer Inc. / TCS
2014 – 2016
- Reviewed and approved GxP validation documents (URS, FR, test scripts, change controls).
- Conducted risk assessments, remediation tracking, and cross-functional review meetings.
- Trained global teams on change management and documentation standards.
TECHNOLOGIES
HP ALM, ERP Systems, CSV Documentation Tools, Change Management Systems
