Head of JJRC Technology Regulatory Compliance
Company: Disability Solutions
Posted on: September 14, 2023
Johnson & Johnson Services Inc. is recruiting for a Head of JJRC
Technology Regulatory Compliance located in Raritan, NJ. Caring for
the world, one person at a time has inspired and united the people
of Johnson & Johnson for over 130 years. We embrace research and
science -- bringing innovative ideas, products and services to
advance the health and well-being of people. With $94.9 billion in
2022 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. There are more than 250 Johnson & Johnson
operating companies employing over 125,000 people and with products
touching the lives of over a billion people every day, throughout
the world. If you have the talent and desire to touch the world,
Johnson & Johnson has the career opportunities to help make it
happen. Thriving on a diverse company culture, celebrating the
uniqueness of our employees and committed to inclusion. Proud to be
an equal opportunity employer. The Head of JJRC Technology
Regulatory Compliance is responsible for leading a global team and
building strong compliance capabilities and culture in the
specialized areas of Technology. The position is responsible for
GxP compliance strategy and operational excellence; serving as
compliance key advisor and subject matter expert to business
partners; enabling compliant innovation and growth; and shaping the
external regulatory environment. This position is responsible for
setting the overall strategy and direction for Technology
Regulatory Compliance, including establishing and overseeing
compliance programs covering GxP computerized systems, Cloud
computing / virtualized data centers, big data, artificial
intelligence, and other emerging technology areas. This position is
instrumental in helping to identify, escalate, and manage risks and
serves as a member of the JJRC and Technology Quality & Compliance
leadership teams. This position reports solid line to the VP
J&J Regulatory Compliance, within the Johnson and Johnson
Regulatory Compliance (JJRC) organization. Key
- Leads a globally dispersed specialized team, within a matrixed
organization, to support a shared services organization that
provides services to all Johnson & Johnson business units.
- Identifies and develops talent to meet the needs of a
fast-paced innovation environment and new business models.
- Partners with Quality and other stakeholders to develop and
deploy compliance strategies and frameworks for a broad range of
innovative and emerging domains.
- Conducts business planning activities, including resource
planning and budget planning.
- Develops business cases to support resource needs and capital
- Engages with senior J&J Technology Quality & Compliance and
J&J Technology leadership, across multiple functions, to serve
as compliance advisor and subject matter expert for GxP activities
related to computerized systems, Cloud computing / virtualized data
centers, big data, artificial intelligence and other emerging
- Owns and governs the execution of compliance programs,
including J&J Technology- Technology Services (JJT-TS) Internal
Quality Audit; Technology Supplier Audit (due diligence and
surveillance); GxP System Periodic Reviews; Standards Management;
Follow-up Programs; Data Center Inspection Readiness; Sector
Inspection support; and Compliance metrics and analytics.
- Understands JJT-TS compliance risk profile, based on compliance
programs and other intelligence (e.g., escalations, regulatory
inspections, etc.), to proactively identify, communicate,
prioritize, address, and manage risk.
- Provides expertise in evaluating and interpreting regulations
at a global level and provides leadership in the identification of
risk mitigation strategies.
- Provides leadership and strategic direction for interactions
with regulators on matters related to technical topics; ensures
subject matter expert preparedness; and reviews communications with
- Engages externally with industry groups and regulators to shape
emerging regulatory policy and partners internally with
JJRC-Enterprise Regulatory Outreach and Regulatory Affairs to
continuously monitor the changing climate and proactively assess
and communicate trends and emerging areas. Owns strategic direction
of Technology related regulatory outreach and associated activities
to ensure alignment with business priorities. Leads the development
of industry comments to proposed specialized regulations and
- Creates and deploys compliance strategies, including authoring
position papers, to enable compliant innovation in emerging
- Partners with Quality and other stakeholders to develop and
deploy compliant digital technology strategies and frameworks.
- Provides partnership, insight, and direction to
cross-functional business leaders and stakeholders regarding TRC
processes, capabilities, and initiatives.
- Serves as compliance partner to Technology and Technology
Quality, providing base business advisory expertise and in the
creation of compliance strategies that enable innovation in
- Establishes and drives sustainable Technology compliance
programs for new technologies.
- Supports strategies and practices to establish a continuous
learning culture that supports talent capabilities, including
future readiness and retention. This includes targeted technical
and business process trainings, guided learnings, compliance
retrospectives, new/changing regulatory
Guidances/positions/enforcement trend debriefs, and allocation of
talent with specific development/exposure goals (e.g. SaMD,
Cybersecurity, etc.) for "ride along or second chair" as part of
the Demand & Supply Intake Process.
- Contributes to talent pipeline efforts focused on identifying
internal and external candidates with a niche skillset in
compliance and technology for future TRC roles.
- Supports new talent on-boarding.
- Manages global teams across geographies including FTEs and
Contractors within a matrixed organization.
- Responsible for the development of direct reports by supporting
the development of Human Resources Planning (HRP) programs
including management development and training 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 force.
- Conducts performance reviews, succession planning, talent
reviews and career development for direct reports.
- Supports JJRC enterprise initiatives and working teams and
supports execution of ERC independent audits and special
- Reviews and provides input to quality and/or technical standard
changes to ensure continued compliance with health authority
- Ensures timely reporting of status and metrics as required by
the JJRC organization.
Keywords: Disability Solutions, New Brunswick , Head of JJRC Technology Regulatory Compliance, IT / Software / Systems , Raritan, New Jersey
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