Quality Information Security

+91-984*******, Chennai, India

adctk9@r.postjobfree.com

LinkedIn of Ganesh

MR. GANESH KUMAR BALRAJ

Certified BPM, 6 Sigma GB, ITIL, ISO Lead Auditor, CSM, Franklin Covey Speed of Trust Heading Chennai Quality & Compliance, and member of Global Q&C Leadership Team Ganesh is a Post Graduate in Quality Management from Anna University and has 19+ years of experience in Process Definition, Implementation, Product Management, Project Management, Testing, Validation & Quality Compliance, and Auditing. Global Experiences in geographies such as USA, Switzerland, Sweden for customers in Life Sciences, Banking, Retail, Information Media industries CORE COMPETENCIES & CERTIFICATIONS

• Strategic Planning and Leadership

• Client and Business Relationship Management

• Staff Development and Team Building

• Product, Program, and Project Management

• Regulatory and Process Compliance, Risk Management, and Testing

• Process Definition and Harmonization

• Auditing and Supplier Assessments

• Process Improvement, Tools Development and Implementation

• Domain and Technological Alignment, and Industry Experience Ambitious, results-oriented leader utilizing innovative technology platforms to drive strategic business

transformation solutions, with a passion for problem solving WHY AM I INTERESTED IN THIS ROLE?

With knowledge and experience gained over years and as being part of the Leadership team, I will be able to lead and coach teams in using innovative and simplified ways for effective compliance Employs quality process and domain awareness to build strategies that complies with Regulations, Standards and satisfies Customer and Business needs, with ability to liaison with Business, Customers, IT, and Executive Management and Delivering Stakeholder value through Cost Effective, Quality Innovation approach

MY EXPERIENCE TIMELINE

KEY ACHIEVEMENTS

Multiple Process Authoring and Definition

Quality Policy Manual

CAPA Management, Exception Management

Supplier Assessment, CSV, SDLC and PM

for key customers as Abbott, AZ, Hospira, HMH, CTS, etc.

Process Harmonizations covering leading industries for Abbott, J&J, GSK and AZ

Multiple Program and Product Quality & Compliance Facilitations

3 Major Global Programs (500+ MM USD) & 100+ Projects

Web 2.0 Process Management, Project Management, and Knowledge Management Tools for key customers as HMH, J&J, CTS, Abbott, AZ, etc.

3 Product Implementation: C2.0, CAPA & Budgeting system for key customers as Abbott, AZ, J&J, Novartis, Walmart, HMH Conducted 100+ Audits and Supplier Assessments

100+ Internal and Customer Audits

25+ Supplier Assessments

26 ISO and Surveillance Audits

2 Regulatory Inspections

2 CMMi Appraisals as ATM

for key customers as Abbott, AZ, CTS, Novartis, J&J, etc. Business Unit Management and Improvements

Generated savings of around 4,000 PH effort/month for the team, and of 80,000 USD/year for a Pharma Customer

Increase of revenue by 25% per month (in MM USD)

15% Y on Y increase in no. of applications made inspection ready

35% increase in Training Compliance for 2 Global Programs KEY RESPONSIBILITIES IN ASTRAZENECA INDIA PRIVATE LIMITED Leadership and Management

Strategizing and defining objectives for Quality and Compliance team

Providing coaching, direction and guidance and lead team of 34 Process, Regulatory, SOx, Quality and Compliance Specialists and focus on improving teams budget, cost, volume and efficiency targets (KPIs) in line with business objectives

Accountable and responsible for overall Quality Solutions to ensure Inspection Readiness through System, Security and GDPR Assessments, and Periodic Reviews

Collaborate with Business, IT, Security and Legal Stakeholders to understand their Regulatory, Quality and Compliance needs and align to their objectives and define Quality Agreements, and active member of Vendor selection process team

Assist Business and IT in streamlining processes, implementation of process tools, providing coaching in CSV, GxP, CAPA management, exception management, risk management, Information Security, GDPR, product and project management Quality Management, Auditing and Testing

Maintaining and improving departmental operational performance to meet requirements of regulatory authorities, organization SOPs, customers and vendors

Envision, Design, Develop and Implement Process tools for IT and Business, and lead manual testing of SOx and Process controls

Driving continuous improvement, simplification and innovation, organization wide quality initiatives such as Management programs, Lean and Induction, and Product Owner for CAPA management product and work with all sprints and plan agile release trains

Minimize organization risk by ensuring IT Vendors and internal systems are audited and assessed for conformity on periodic basis

Work along with global teams that are culturally and geographically distributed Product Management, Project Management and Operations Quality

Envisioned and Spearheaded design, development and ontime rollout of CAPA management product, and Budgeting and Recharge tool

Scheduling, Budgeting and resource management of QMs, comply with regulatory, legal and SEZ restrictions, and manage P&L KEY RESPONSIBILITIES IN COGNIZANT TECHNOLOGY SOLUTIONS INDIA PVT. LTD.

Manage, Mentor and Coach large teams and Global IT programs ranging above 500MM USD from Quality Process, Compliance, SDLC, Agile, and Validation perspective

Leading teams in studying Business and IT process of Top10 Pharma Customers and harmonize their Validation and Testing methodology, and IT SOPs in line with regulations and best practices

Process Author and Owner for QPM, SEPG, Project Management, Quality, Testing and LS Validation processes

Global stakeholder management till Senior Executive Management level of Customer Organizations and of Cognizant

Understand and ensure compliance from business, legal, contractual, and regulatory aspects of the respective geographies

Hands on experience in managing process tools, project delivery and validation

Providing Quality, Process and Tools Consultation services and Envisioning end-to-end solutions for clients by combining knowledge, experience, and skills gained from business operations, analytics and IT applications, with Global delivery exposure

Driving Quality and Continuous Improvement initiatives and implementation of PM, Eclipse Process Authouring and KM tools with Web2.0 capabilities, and COTS tools

Automate various reporting components for Quality team by applying Lean concepts to ensure operational excellence

Lead and involved with 3rd party auditors of KPMG, DNV, Trimentus, Deloitte for ISO, CMMI, Customer and Regulatory audits

Conduct coaching on problem solving, contract negotiation, risk management, security and planning KEY RESPONSIBILITIES IN EARLIER ORGANIZATIONS

Responsible for large scale corporate level IT initiatives in testing, quality, compliance, and auditing

Process Implementation and Testing for banking and construction projects

Streamlining of processes and implementation of defined process and tools CREDENTIALS AND KEY ENDORSEMENTS

Certified in Leadership trainings as Leading at the Speed of Trust by Franklin Covey

Certified Bullet Proof Manager (completed projects on Problem Solving, and Leadership Skills using Moments of Truth)

Certified in IT Service Management Foundation (ITIL 2.0) Foundation by Exin, and trained by Cognizant in ITIL v3

Certified Scrum Master by Scrum Alliance

Certified Six Sigma Green Belt and Lean - completed projects on Optimizing Productivity

Internal certification on CSV, GxP, GAMP, 21 CFR Part 11, PMP, Validation, Information Security, Lead Auditor, Leadership and Soft skills

Core participant for ISO 9001:2008 and ISO 13485:2003 certification journey, and Assessment Team Member (ATM) for CMMI and CMM

Trained in project management, testing concepts, tools and techniques, and used testing tools

Associated member of multiple forums and groups in quality process, project management, testing, and pharmaceutical industry

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