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Roles and responsibilities

• Support KPMG's Quality Compliance Remediation Practice by leading teams


to deliver computer systems validations (CSV) projects FDA, Part 11

Consultant /
Provide regulatory compliance and computer validation guidance and support
to KPMG clients
• Participate is fast paced engagements, managing a team of 3-5 resources

AM, •


Assist in developing Software Development Life Cycle (SDLC) CSV strategy,
templates and standard operating procedures
Create system validation deliverables (validation plan, user requirements, risk

Managemen •
analysis, test protocols, validation reports)
Perform a risk analysis; Plan and coordinate the validation testing and

t Consulting
perform system audits for compliance with best practices and regulatory
requirements

– Life
Sciences – Required
Education / professional Prior Experience:

CSV
qualifications The candidate must have 4-8 years of relevant
MBA from a reputed college experience in a similar role, working with life sciences
companies.

About us Experience & Background


KPMG is a leading professional services firm • Awareness of various types of enterprise platforms used within Medical
comprising over 174,000 professionals who Device & Pharma industries for running their business: Quality Management
work together to deliver value in more than Systems, Document Management Systems, and Training Systems
155 countries through in-depth industry • Experience and good understanding of the regulations and industry
insights in Audit, Tax & Advisory. The firm standards such as ISO, ITIL, COBIT, GAMP, Prince 2 and PMBOK
recorded more than USD 24.4 billion in • Background in management consulting with a track record of successful
revenues in 2015. engagement management and experience in delivering client presentations
Roles and responsibilities
• Support KPMG's Life Sciences Practice by leading teams to deliver computer
systems validations (CSV) projects FDA, Part 11, EU MDR Transformation

Manager,
Assist in developing Software Development Life Cycle (SDLC) CSV strategy,
templates and standard operating procedures
• Support Regulatory Affairs transformation projects for Life Sciences clients

Managemen •


Perform analysis on regulatory-related data, processes, business
requirements, operating models, etc.
Support delivery of advisory services to Life Sciences clients, primarily with

t Consulting services related to product serialization, supply chain process and solution
design

– Life
• Lead gap assessments to determine the client's current state, and develop to-
be processes, including options and recommendations for critical issues
• Document serialization requirements, data architecture models, and

Sciences •
pharmaceutical supply chain processes
Provide input into engagement decisions, including work plan and timeline,
project management, resource allocation, and career development of staff
members
• Execute process transformation, measurable improved operational
performance, and organizational restructuring

About us
• Identify and communicate performance improvement opportunities for clients

KPMG is a leading professional services firm Required


comprising over 174,000 professionals who
work together to deliver value in more than Education / professional Prior Experience:
155 countries through in-depth industry qualifications The candidate must have 7-15 years of relevant
insights in Audit, Tax & Advisory. The firm MBA from a reputed college experience in a similar role, working with life sciences
recorded more than USD 24.4 billion in companies.
revenues in 2015.

Experience & Background


• Awareness of various types of enterprise platforms used within Medical
Device & Pharma industries for running their business: Quality Management
Systems, Document Management Systems, and Training Systems
• Experience with Good Manufacturing Practice (GMP) and Good Distribution
Practice (GDP)
• Experience and good understanding of the regulations and industry
standards such as ISO, ITIL, COBIT, GAMP, Prince 2 and PMBOK
• Strong understanding of Regulatory Affairs related data and documents
• Background in management consulting with a track record of successful
engagement management and experience in delivering client presentations
• Excellent foundational skills including strong analytical, written and verbal
communication skills, MS Office expertise, impactful client presence,
compelling facilitation and presentation skills
• Knowledge of business requirements, process modeling, simulation, and
high-level design activities
Roles and responsibilities
• Support Regulatory Affairs transformation projects for Life Sciences clients
• Drive progress against project milestones to help ensure timely delivery of

Consultant /
project deliverables, review the work product of associates, and provide
direction and training as necessary
• Provide input into engagement decisions, including work plan and timeline,

AM,
project management, resource allocation, and career development of staff
members
• Perform analysis on regulatory-related data, processes, business

Managemen •
requirements, operating models, etc.
Execute process transformation, measurable improved operational

t Consulting
performance, and organizational restructuring
• Identify and communicate performance improvement opportunities for clients

– Life
Sciences – Required
Education / professional Prior Experience:

Regulatory
qualifications The candidate must have 4-8 years of relevant
MBA from a reputed college experience in a similar role, working with life sciences

Operations
companies.

Experience & Background

About us • Experience with operational process improvement initiatives in a


pharmaceutical and/or medical device industry; prior professional services or
consulting experience preferred
KPMG is a leading professional services firm
• Strong understanding of Regulatory Affairs related data and documents
comprising over 174,000 professionals who
work together to deliver value in more than • Excellent foundational skills including strong analytical, written and verbal
communication skills, MS Office expertise, impactful client presence,
155 countries through in-depth industry compelling facilitation and presentation skills
insights in Audit, Tax & Advisory. The firm
recorded more than USD 24.4 billion in
• Experience and good understanding of the regulations and industry
standards such as ISO, ITIL, COBIT, GAMP, Prince 2 and PMBOK
revenues in 2015.
• Background in management consulting with a track record of successful
engagement management and experience in delivering client presentations
Roles and responsibilities
• Support delivery of advisory services to Life Sciences clients, primarily with
services related to product serialization, supply chain process and solution
design

Consultant / • Lead gap assessments to determine the client's current state, and develop to-
be processes, including options and recommendations for critical issues

AM,
• Document serialization requirements, data architecture models, and
pharmaceutical supply chain processes
• Create dashboards and trackers to measure the progress and performance of

Managemen •
supply chain and regulatory operations processes
Support the creation of KPMG service offerings in the form of marketing

t Consulting
collaterals and proposal presentations
• Support engagements according to KPMG's financial/cost management
policies

– Life
Sciences – Required

Technical
Education / professional Prior Experience:
qualifications The candidate must have 4-8 years of relevant
MBA from a reputed college

Operations
experience in a similar role, working with life sciences
companies.

About us Experience & Background


• Experience with Good Manufacturing Practice (GMP) and Good Distribution
Practice (GDP)
KPMG is a leading professional services firm
• Global project management experience, and/or PMP Certification
comprising over 174,000 professionals who
work together to deliver value in more than • Knowledge of business requirements, process modeling, simulation, and
high-level design activities
155 countries through in-depth industry
insights in Audit, Tax & Advisory. The firm • Background in management consulting with a track record of successful
engagement management and experience in delivering client presentations
recorded more than USD 24.4 billion in
revenues in 2015.