Quality Systems Consultant Job Description - PathWise
Position:
?Quality
?Systems
?Consultant
?
About
?the
?Job
?
PathWise,
?Inc.
?is
?a
?world-?©\class
?management
?consulting
?and
?training
?firm
?that
?improves
?business
?
processes
?of
?client
?companies.
? Our
?clients
?include
?the
?FDA
?as
?well
?as
?many
?top
?medical
?device
?and
?
pharmaceutical
?organizations.
? PathWise
?provides
?instructor-?©\led
?training
?programs
?and
?a
?variety
?of
?
quality-?©\based
?consulting
?services.
? The
?PathWise
?system
?of
?consulting
?and
?learning
?is
?designed
?to
?
support
?the
?most
?critical
?factors
?for
?organizational
?and
?individual
?success
?within
?the
?Life
?Science
?
industry.
?
?Our
?focus
?is
?on
?improving
?all
?aspects
?of
?quality
?systems
?and
?maintaining
?compliance
?with
?
regulatory
?bodies.
?
?
PathWise
?is
?a
?values-?©\based
?organization
?with
?a
?unique,
?family-?©\like
?culture.
? A
?Consultant
?is
?responsible
?
for
?providing
?scope
?and
?planning
?to
?consulting
?implementations
?and
?managing
?performance
?of
?an
?
implementation.
?The
?Consultant
?will
?interact
?with
?the
?sales
?team,
?product
?development
?team,
?and
?
training
?team
?internally.
? This
?individual
?will
?also
?interact
?directly
?with
?client
?teams.
?
?
Scope
?of
?Consultant
?
?
Responsibilities:
?
?
?
?
Provide
?scope
?and
?planning
?to
?consulting
?implementations
?
? Scope
?out
?new
?consulting
?projects
?
? Develop
?implementation
?plans
?with
?Clients
?and
?Managers
?
? Recommend
?process
?and
?procedural
?improvements.
?
? Maintain
?and
?apply
?knowledge
?of
?current
?policies,
?regulations,
?and
?industrial
?
processes.
?
? Implement
?proposed
?improvements
?
? Perform
?GAP
?analysis
?or
?audits
?of
?customer
?facilities
?or
?suppliers
?
Work
?with
?internal
?and
?external
?customers
?to
?improve
?processes
?by
?providing
?
technical
? guidance
?to
?quality
?teams,
?identify
?key
?work
?to
?be
?performed,
?build
?
cross-?©\functional
?and
? collaborative
?project
?teams,
?initiate
?action,
?lead
?efforts
?and
?
achieve
?deadlines.
?
?
Travel
?Requirements:
? Approximately
?50%
?to
?70%.
? International
?travel
?may
?be
?required.
?
?
?
Job
?Competencies:
?
Technical
?competencies:
?
?
?
?
?
?
?
Technical
?writing
?
Procedure
?Writing
?
Project
?Management
?
Planning
?and
?organizing
?
FDA
?and
?other
?country
?regulations
?and
?requirements
?
?
?
?
Quality
?Systems
?Auditing
?
Presenting
?to
?top
?level
?management
?
Business
?Skills:
?
?
?
?
?
?
?
?
?
?
?
?
Ability
?to
?positively
?influence
?a
?team
?
Strong
?Interpersonal
?skills
?
Verbal
?and
?written
?communications
?skills
?
Ability
?to
?learn
?technical
?information
?on
?their
?own
?
Managing
?stress
?when
?faced
?with
?short
?deadlines
?and
?change
?
Work
?alone
?in
?home
?office
?
Communicates
?and
?works
?well
?in
?a
?virtual
?organization
?
Ability
?to
?lead
?a
?virtual
?team
?
Self-?©\starter
?
Software
?Skills:
?
?
?
?
?
?
?
?
?
?
?
MS
?Word
?(mid-?©\level
?skills
?or
?better)
?
MS
?Outlook
?
MS
?Power
?Point
?(expert
?skill
?level)
?
MS
?Excel
?
Visio
?
Ability
?to
?navigate
?the
?Internet
?
SharePoint
?
MS
?Projects
?or
?equivalent
?
?
?
?
QUALIFICATION REQUIREMENTS:
?
BA in Life Science, Communications, Business, or equivalent experience (MS in a Life Science,
Management, MBA, or PhD in a life science is preferred)
?
Six Sigma Green Belt and/or Black Belt preferred
?
CQE and/or CQA is Preferred
?
High level of proficiency in Visio,
?MS Word, Excel, PowerPoint and Project
?
Must effectively multi-task and manage time to meet deadlines under minimal supervision
?
Experience in FDA remediation as well as other regulatory bodies remediation
?
Possess a proven track record of leading consulting teams through the full cycle of the client
implementations, GAP, Planning, Implementation, and Verification
Other Skills and Abilities:
Qualified candidates will possess excellent written and verbal communication skills, and have the
ability to present, train, and consult on technical and non-technical information clearly and
concisely. Successful candidates must be flexible. Must be able to relate to project managers
and clients with diverse backgrounds and exp
?
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