Head of Quality Management Systems & Enabling Platforms Technology Quality
Company: Johnson & Johnson
Location: Raritan
Posted on: February 25, 2021
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Job Description:
Job DescriptionJohnson and Johnson is recruiting for a(n) Head
of Quality Management Systems & Enabling Platforms Technology
Quality. The preferred location for this role is Raritan, NJ, but
we can consider alternate J&J locations globally. This position
may require up to 20% travel (domestic and international).Caring
for the world, one person at a time has inspired and united the
people of Johnson & Johnson for over 125 years. We embrace research
and science -- bringing innovative ideas, products and services to
advance the health and well-being of people.With $82.1 billion in
2019 sales, Johnson & Johnson is the world's most comprehensive and
broadly based manufacturer of health care products, as well as a
provider of related services, for the consumer, pharmaceutical, and
medical devices markets. Employees of the Johnson & Johnson Family
of Companies work with partners in health care to touch the lives
of over a billion people every day, throughout the world.Technology
Quality and Compliance (TQ&C) manages the Quality and
Compliance strategy for IT systems including applications,
infrastructure and digital health solutions for J&J. TQ&C
is the Subject Matter Expert (SME) for validation/qualification of
both applications and infrastructure in accordance with J&J's
Systems Development Life Cycle (SDLC) and Computer System
Validation (CSV) Framework, assuring compliance across the
enterprise with applicable global regulations, advising on quality
matters, and assisting with closing compliance gaps related to
audits and inspections.The Head of Quality Management Systems &
Enabling Platforms - New Health Platforms, Technology Quality &
Compliance ensures compliance of medical device software (SaMD) and
product hosting infrastructure, both internal and hosting
platforms, across the enterprise in accordance with internal
policies/procedures and external regulations.* The role is
responsible to ensure full compliance and adherence to company
policies and procedures by providing compliance leadership,
strategic direction and day to day operational support to Health
Technology projects and base business support teams* This position
is also responsible for providing regulatory compliance expertise
and supporting any compliance related remediation efforts* This
position will support internal and external health authority
regulatory inspections * The position will be responsible for
managing resources responsible for the approval of validation
documentation deliverables including the approval to release system
implementation and/or changes for production use* Attend project
team meetings and provide compliance guidance and support to
project and base business support team members* This role will
provide an environment which encourages the company's credo and the
value of a diverse workforce* This role will lead globally diverse
teams in an inclusive environment* This role serves as a trusted
partner across the Technology Quality & Compliance organization,
requiring strong collaboration skills at the senior leadership
level, and includes making recommendations for improvements
relevant to senior level stakeholdersKey ResponsibilitiesCore
Responsibilities * In conjunction with franchise quality assurance
teams, provides quality oversight in support of engineering,
release and post-market support activities for:* SaMD - Standalone
software medical devices (i.e. mobile, wearables, web
applications)* Hardware integrated solutions such as software
driven surgery systems (robotics)* Digital manufacturing and 3D
printing* Medical device infrastructure, including IaaS and
internal hosting of product software* Actively participates in all
stages of design development, V&V testing and release/support
activities, ensuring quality assurance considerations and
requirements are met* Manages resources who are responsible for
review of product deliverables per QMS requirements* Supports
post-market quality activities such as change management, product
complaint handling, and Deviations/CAPAs* Facilitates and
communicates key strategies and business process initiatives to
various cross-functional groups to gain support * Provides
partnership, insight and direction to cross-functional business
leaders and stakeholders regarding policies, solutions and
initiatives* Utilizes knowledge of the assigned business functions
to identify business needs and develop value-added solutions*
Identifies potential gaps with in-scope systems, and coordinates
remediation with business and IT alignment* Ensures a high degree
of inspection readiness for systems within scope of responsibility
* Participates in audits, approves audit non-conformity action
plans and approves closure of internal audit findings* Develops
KPIs and measures and reports/communicates performance * Develops
continuous improvement programs to improve overall quality of
delivered solutions* Develops personnel development and training
programs for medical device software support, including both
quality and IT* Designs and implements a Software Medical Device
and product hosting infrastructure knowledge repository* Action any
NPS comments, provide resolution back to Strategic Planning &
Transformation* Partners with the Supplier/procurement organization
to ensure supplier management processes are implemented and
measured * Partners with Business Quality organizations for
defining handoffs, roles and responsibilities on SAMD * Partners
with Business Quality organizations to define business risks which
can be mitigated by system modifications* Partners with Systems &
Infrastructure Assurance organization to transition new programs
post initial deployment * Relationship with the segment Quality
Organizations for ensuring Quality Agreements are documented and
measured. * Partners with Strategic Planning & Transformation to
ensure KM database is populated* Partners with Technology
Regulatory Compliance (TRC) to ensure compliance requirements are
embedded into Quality Strategies* Partners with Reliability &
Operational Assurance to ensure the periodic review process embeds
the review of GxP controls* Ensures Feedback from Reliability &
Operational Assurance is assessed to continuously improve the
Quality Strategies* Partners with Reliability & Operational
Assurance to devise strategy to measure adherence to Quality
strategies* Tracks and documents quantifiable business results
achieved from project work and writes success stories for
publication that demonstrate the business value created by
TQ&CStakeholder Management* Manages global teams across
geographies including FTEs and contractors within a matrixed
organization* Manages project/department budgets * Establishes
yearly business plans for respective area* Responsible for the
development of direct reports including training and mentoring to
meet current and future business needs* Provides an environment
which encourages the company's credo, commitment to equal
employment opportunity and the value of a diverse work forcePeople
Management* Participates in external/industry peer groups which
focus on best practices for quality and validation of software
medical devices and product hosting infrastructure platforms*
Hosts/supports benchmarking sessions with peers to gain insights on
industry trends in the medical device software space* Works with
TQ&C leadership and pillar leaders to nurture future leaders
and create opportunities to grow* Mentors talent and helps them
grow in their careers* Supports supplier audits as neededOther
Duties* Develop and maintain an effective working partnership with
senior management* Collaborate with other leaders and staff within
Technology Quality and Compliance group to ensure each function is
executed in an efficient manner* Ensure adherence to the TQ&C
Operating Model* Ensure timely reports of status, metrics and time
sheets as required by the Technology Quality and Compliance
organization* Ensure timely completion of assigned training and
expense reportsQualifications* A Bachelor's degree in computer
science, engineering, information systems, business administration
or other related field required; advanced degree preferred; solid,
relevant experience may be substituted when appropriate; additional
certifications a plus* A minimum of 10 years of progressive
experience in the pharmaceutical/med device/biotech industry, with
direct experience in healthcare technology quality management is
required* A minimum of 7 years of people management experience is
required* Experience with medical device software, including
standalone systems is required * Experience with integrated
hardware projects such as robotics and 3D printing platforms is
preferred* Experience with infrastructure qualification and quality
assurance activities for both internal and hosted platforms is
preferred* Experience in defining and implementing quality strategy
and supporting programs, especially focused on medical device
software and supporting product hosting infrastructure platforms is
required* Extensive experience in IT methodologies including: Agile
Development, ITIL, COBIT and GAMP 5 is required* Working knowledge
of information and product cyber security is preferred * Knowledge
of GxP and medical device standards and regulations is required*
Certified Software Quality Engineer (CSQE), Certified Quality
Engineer (CQE), Certified Quality Auditor (CQA), Project Management
Professional (PMP) or similar is preferred* The preferred location
for this role is Raritan, NJ, but we can consider alternate J&J
locations globally. This position may require up to 20% travel
(domestic and international). Johnson & Johnson is an Affirmative
Action and Equal Opportunity Employer. All qualified applicants
will receive consideration for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, age,
national origin, or protected veteran status and will not be
discriminated against on the basis of disability.
Keywords: Johnson & Johnson, Trenton , Head of Quality Management Systems & Enabling Platforms Technology Quality, Executive , Raritan, New Jersey
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