Sanjeev Kumar
Sr. Director -Cell and Gene Therapy - QA-Ops
- Role
- Sr Director - Cell and Gene Therapy - Qa-ops at Vertex Pharmaceuticals
- Location
- Wellesley, MA, US
- LinkedIn followers
- 500 followers
About Sanjeev Kumar
High performing, results driven leader with proven track record of envisioning and leading strategic initiatives geared toward enhancing overall state of compliance. Skilled team player and consensus builder with strong negotiating and influencing skills. Hands on experience of developing and implementing Quality Management Systems, Corporate Policies, End-to End QA Processes, Life Cycle methodologies and CMOs - CROs Audit and Risk Management programs.Hands-on expertise in on-boarding public / private cloud based service providers. Skilled strategist and effective change agent, with demonstrated ability to transform strategic plans in to implementable actions with measurable outcomes.Successfully led and mentored cross-disciplinary teams in multi-site global environment, to deploy Information Systems for R&D and Lab specific business entities.Contributed in development of FDA’s 21 CFR Part11 guideline document, released in May 2005.Specialties: Quality Systems, Continuous Manufacturing, GxP Regulations, Data Life Cycle, FDA, MHRA, EMA Inspections, Remediation
Experience
Sr Director - Cell and Gene Therapy - Qa-ops
Jul 2023 — Present · Boston, MA, US
Education
Schulich School of Business - York University
MBA, Ongoing
2008
Unniversity Department of Chemical Engineering and Technology, Panjab University
Bachelor of Engineering - BE, Chemical Engineering
1985 — 1989
Schulich School of Business
MBA; Ongoing, Project Management, Finance
Schulich School of Business - York University
Master of Business Administration - MBA, Accounting and Finance
Punjab University
B. Engineering, Chemical Engineering & Technology
Punjab University
B.Engineering, Chemical Engineering & Technology
Skills
- Slc
- Change Management
- Automation Systems
- Quality Management Systems
- Gxp
- Project Management
- Sdlc
- Pharmaceutical Industry
- Fda
- Medical Devices
- Document Management
- Capa
- Gmp
- Computer System Validation
- Strategy
- Continuous Manufacturing
- Business Analysis
- 21 Cfr Part 11
- Glp
- Change Control
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