Senior Director, Business Support

Compensation

: $177,070.00 - $177,070.00 /year *

Employment Type

: Full-Time

Industry

: Executive Management



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Senior Director, Business
Support





Locations : US (NJ/Philadelphia), Belgium (Beerse) or NL
(Leiden)





PG 41











Principle responsibilities













+ Member of, and
active participant in, the CMC RA SLT. Partners with other SLT members to ensure
high performing organization and consistent application of practices, policies,
systems and programs



+ Planning,
organizing, and directing resources and activities within CMC RA



+ Coordination of
selected initiatives within CMC RA / GRA



+ Supervise and
provide leadership and oversight for CMC RA staff



+ Assures that appropriate objectives and metrics are established,
monitored and met, including removing barriers



+ Responsible for training, coaching and development of the team members



+ Drives a culture of continuous improvement to
ensure compliance with Johnson and Johnson standards, regulatory requirements
and expectations. Communicates critical issues to Senior
Management



+ Represents CMC RA
on Cross Functional Governance Committees



+ Serves as a
thought leader on internal and external teams to proactively influence Health
Authority Policy and practice on CMC issues



+ Creates engagement and a culture of collaboration flexibility, and
competitiveness by increasing business and scientific acumen, industry
knowledge and skills



+ Enables a culture of performance driving a more flexible organization
using levels as process improvement and innovation



+ Drive implementation of strategic plans









































Sphere of Authority













+ Responsible for
talent and development management strategy in line with the GRA strategy within
his/her group



+ Design and embed
efficient business processes and drive continuous improvement of working
practices to maximize the efficiency of the CMC RA team.



+ Drive operational
efficiencies and effectiveness for Global CMC RA that optimizes the
department's capabilities and enhances overall quality, efficiency and
productivity by ensuring systems are fit for purpose and utilized
effectively.







+ Oversight of
department data by ensuring process flows and job aids are developed,
maintained and trained on and that data entry follow appropriate guidelines.



+ Identify and
implement new tools and systems. Provide training and mentoring for the use of
IT systems



+ Responsibility
for the implementation and monitoring adherence to Guidance, Policies &
Procedures applicable to CMC RA, produce monthly performance reports



+ Ensures global
regulatory filings for development compounds and marketed products are
supported with relevant C&S and country specific requirements in
collaboration with CMC RA personnel and global teams.












Qualifications



Position Requirements













+ BS in biological,
pharmaceutical, chemical or engineering sciences with generally a minimum of 15
years of experience inclusive of post graduate education and/or pharmaceutical
or health care industry experience or equivalent. An MS, Ph.D., or Pharm. D. degree preferred



+ Minimum of 5 years demonstrated leadership and people development
skills within a regulatory function preferred



+ Successful experience in leading a diverse community of professionals
in a global and matrix environment. Seasoned leader, decision maker and
constructive challenger



+ Solid
understanding of biology, chemistry and/or engineering relevant to
pharmaceutical industry is preferred



+ Proven track
record and/or deep understanding in developing and implementing successful CMC
regulatory lifecycle strategies and seen as an expert on product development
and how it is applied to global regulatory strategy



+ Strong attention
to detail with high-level verbal and written communication skills



+ Makes decisions
based on facts and sound scientific principles



+ Ability to
interact with all levels in the organization



+ Communicates
cross-functionally and cross-company; presents and defends CMC
management-approved regulatory strategy to project teams; recognizes and
accounts for global regulatory impact



+ Demonstrates
model behavior that understands what the priorities are and encourages others
to drive for results





































Primary Location

Belgium-Antwerp-Beerse-

Other Locations

North America-United States-New Jersey, North America-United States-Pennsylvania-Philadelphia, Europe/Middle East/Africa-Netherlands-South Holland-Leiden

Organization

Janssen Cilag N.V./S.A. (7025)

Job Function

Regulatory Affairs

Requisition ID

00002B
Associated topics: analyst, endowment, festival, newspaper, policy, policies, presale, public, regulatory, social media * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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