Senior Director, Global Quality Operations
Company: Otsuka Pharmaceutical
Posted on: September 21, 2022
Job SummaryResponsible for the leadership and oversight of the
following functions within Global Quality Operations; GxP training,
GxP risk management and GxP document management services and GxP
Systems.-- Provides strategic leadership and guidance expertise for
global and regional quality activities and staff to ensure
compliance with global regulations.-- This role will provide
strategic, tactical, and technical/operational guidance regarding
GxP (GMP, GLP, GCP) compliance with current pharmaceutical laws and
regulations.-- The incumbent will work closely with the key
stakeholders of Global Regulatory Affairs and Quality Assurance to
enable and coordinate across global quality activities.Job
- Develop and implement innovative solutions that will simplify
the development and manufacturing of key products and deliverables
within the Global Quality teams, identifying inefficiencies, and
ensuring those solutions are viable and incorporated as per
- Establish relationships within the broader organization and
support projects that will have material impact on our business
- Lead project management activities for special business
initiatives across the Global Quality portfolio.
- Oversee change management efforts to support process
improvements, updated workflows, and organizational changes.
- Ensure communications between the team, line management and/or
senior management are handled in an efficient, effective, and
timely manner, to ensure a "no surprises" management environment.--
Included in this would be oversight of Global Quality Leadership
- Be the point person on the Global Quality budgeting process and
actual spend vs. budget.
- Included in the above point person role related to budget is
the oversight across all Global Quality pillars at the portfolio
level as Finance point of contact for project spend and oversight
of pillar management as it relates to purchase order management
- Provides strategic oversight and guidance over Global Quality
operations, stakeholder engagement model - technology and
information portfolios.-- Provide feedback, direction, and insight
to senior management as needed.
- Establishes regional and global strategic programs for quality
as it relates to the health of the quality management system.
- Provides guidance and leadership on planning, execution, and
measurement of key quality activities globally with particular
focus on Risk Management, GxP Training Document Managed Services
and GQ Operations.
- Lead continuous improvement activities e.g., special pilots,
prototypes, collaborations, and projects to digitalize the quality
- Maintain a long-term vision of Global Quality to ensure the
team is evolving with the changing needs of the business and
- Responsible to develop and implement corporate and/or
organizational policies and procedures.
- Provide appropriate mentoring and coaching to quality
operations with respect to technical skills, business practices,
communication and team building to foster a collaborative work
- Develop enterprise-wide solutions across Otsuka that are
aligned with the strategic goals of the GQ organization and that
lead to measurable business outcomes/results.----
- Partner with internal and external stakeholders to understand
and drive efficiency across Global Quality's processes and
operations via automation and digitization, serving as an enabler
of transformation across existing GQ systems, future processes, and
- Provide strategic oversight to bring industry best practices
from a variety of disciplines and--solutions (i.e., quality,
automation, machine learning, and artificial intelligence, etc.) to
expand the QMS roadmap that will continue to expand and enhance
quality practices and business enablement to a best in class, agile
and digital landscape.
- Lead assigned functional groups, departments, and regions to
identify opportunities with efficiencies and effectiveness across
key areas within QMS, e.g., Observations, Findings, Defects, CAPA's
to achieve the goals and objectives of the Global Quality
organization and Otsuka to deliver quality products to our
- Interact with the various business groups within the Global
Quality team and support each in how to effectively manage items
assigned within the QMS to ensure expediency and quality
- May act as Quality Representative for project information
dissemination to internal stakeholders, alliance partners and other
company vendors, as applicable. ----Qualification
- Advanced degree required (e.g., MS, MPH, NP, PhD, MD etc.) with
a minimum of 10 years of applicable health care, technology or
industry is experience strongly preferred.
- credibly, knowledgeably, and effectively. Advanced analytic
skills, and general understanding of the drug development and
- Successful track record of leadership and timely delivery of
innovative business deliverables.
- Strong communication, interpersonal and alliance management
skills; possessing the ability to represent and communicate
initiatives to internal and external KOLs/stakeholders, various
stakeholders in the medical/healthcare community, Otsuka's
partners, and clinical trial personnel credibly, knowledgeably, and
- Understanding of technological trends and passion to develop
innovative solutions that support and enhance medicine, science,
and research to increase Otsuka's competitive edge.
- Ability to work effectively in a matrixed, multi-cultural,
collaborative, and self-directed environment.
- Strong project management experience, with the ability to
successfully engage in multiple initiatives simultaneously.Annual
Salary Minimum $193,000 - Maximum $276,000, plus annual incentive:
The range shown represents a typical pay range or starting salary
for candidates hired to perform work in the state of Colorado.
Other elements may be used to determine actual salary such as the
candidate's job experience, specific skills, and comparison to
internal incumbents currently in role. This information is provided
to applicants in accordance with the Colorado Equal Pay for Equal
Work Act.Company benefits: comprehensive medical, dental, vision
and prescription drug coverage, company provided Basic Life,
AD&D, Short-term and Long-term Disability insurance, tuition
reimbursement, a 401(k) match, PTO allotment each calendar year,
paid holidays, and paid leave programs as well as other company
Keywords: Otsuka Pharmaceutical, Trenton , Senior Director, Global Quality Operations, Accounting, Auditing , Princeton, New Jersey
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