Associate Director - Labeling Quality - REMOTE
Company: Takeda Pharmaceutical
Posted on: May 13, 2022
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The Associate Director, GRA Labeling Quality, is responsible for
the strategic and operational activities pertaining to global and
local labeling quality within Global Labeling and Global Regulatory
Partners with internal stakeholders and external CRO partners such
as Global Regulatory Compliance, Global Labeling, IT, Global
Regulatory Operations, GPSE (safety), Regulatory Therapeutic Areas,
Local Operating Companies and Supply Chain on all matters related
to global labeling quality.
With the Director of Global Labeling Quality, is responsible for
successful labeling quality management, end-to-end tracking of
global labeling updates, and implementation of Global Labeling
As a member of a growing Global Labeling Quality organization, is
involved in setting the direction for the team within Takeda,
identifying and attracting the best talent to the organization, and
strategizing the future of the organization with the Director of
Labeling Quality and others.
No. of direct reports: 0-1
No. of indirect reports: 0-2
Collaborates with Global Labeling leadership to ensure clear and
timely communication about labeling quality activities and
Responsible for alignment with global strategic initiatives related
to labeling events and the processes and systems used to manage
Development and leadership of the following activities at a global
level in collaboration with Head of GRA Labeling Quality:
Responsible for labeling quality-relevant strategic initiative
activities which may impact labeling compliance and labeling
processes (labeling event management systems, RIM systems, and
With Global Labeling Operations, develop new and updated processes
for labeling and labeling quality, as required.
Provide Global Labeling Quality support for internal and external
audits: Ensures inspection readiness
Coordinates Global labeling documentation requests prior to, during
and in follow up to inspections/audits
Provide support to Global Labeling SMEs on presentations related to
global labeling processes for inspections and audits
Supports the development of responses and CAPAs related to global
labeling for audits/inspections
Ensures Labeling Commitments to partners and third parties are
documented and tracked in the appropriate repository
Escalate issues/problems to senior management as needed.
Provides input on budgets for the group as appropriate.
Maintains strong knowledge of current regulations, legislation,
best practices, and guidelines relating to Regulatory Affairs and
Represents Takeda at relevant Industry Forums e.g., LabelNet.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise (Breadth and depth of
knowledge, application and complexity of technical knowledge)
Strong knowledge of business area and regulatory environment and
ability to identify and proactively manage the interactions
necessary for achieving business goals and objectives
Ability to identify proactively and anticipate risk of
non-compliance in a complex environment
Demonstrated knowledge of global health authorities, regulations,
product approval, labeling, and lifecycle processes for major
markets and of pharmaceutical and regulatory affairs requirements
Familiarity with inspections and audit procedures
Excellent analytical, technical, and problem-solving skills (TQM or
Six Sigma experience preferred).
Project management abilities
Leadership (Vision, strategy and business alignment, people
management, communication, influencing others, managing change)
Demonstrated ability to work across functions, regions and
Excellent communicator, able to persuasively convey both ideas and
data, verbally and in writing
Proven skills as an effective team player who can engender
credibility and confidence within and outside the company
Ability to distil complex issues and ideas down to simple
Embraces and demonstrates a diversity and inclusion mindset and
role models these behaviors for the organization
Personnel management experience
Decision-making and Autonomy (The capacity and authority to make
organizational decisions, autonomy in decision-making, complexity
of decisions, impact of decisions, problem-solving)
Comfortable making decisions about corrective and preventative
actions related to labeling events
Ability to work independently on labeling quality activities
Able to manage both time and priority constraints and to manage
multiple priorities simultaneously
Interaction (The span and nature of one's engagement with others
when performing one's job, internal and external relationships)
Efficiently/actively manages conflict in a tactful, diplomatic way,
seeking effective solutions for all parties.
Effectively manage complex topics and a matrixed environment,
building strong relationships with stakeholders enterprise-wide
Innovation (The required level of scientific knowledge, knowledge
sharing, innovation and risk taking)
Forward-thinking with the ability to influence and effectively
drive organizational change and continuous innovation
Comfortable challenging the status quo and bringing forward
Ability to take risks implementing innovative solutions,
accelerating timelines throughout processes
Complexity (Products managed, mix of businesses, internal and/or
external business environment, cultural considerations)
Ability to work in a global ecosystem (internal and external) with
a high degree of complexity
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelor's degree (or equivalent) required. - Masters
8+ years experience in Pharmaceutical or Medical Device industry,
with 5 years in Regulatory Affairs, labeling or quality
Systems Knowledge - extensive knowledge of Quality Management
Systems, including EDMS, and Deviation (Trackwise) systems.
Regulatory Familiarity - extensive knowledge of European, US and
international regulations relative to labeling.
Industry Knowledge - strong understanding of the pharmaceutical
industry and pharmaceutical companies' operations processes and
strategies including Regulatory Affairs processes.
Analytical Skills - ability to identify the critical issues of
problems or opportunities using appropriate information; determines
the causes and possible solutions to the problem.
Communication - ability to express oneself clearly and concisely to
a variety of audiences. Ability to understand/analyze/synthesize
and communicate to internal/external stakeholders.
Teamwork - Ability to work with team members in a friendly,
professional manner. Motivate and empower others. Manage teams to
work productively in a high-pressure environment.
Knowledge Sharing - ability to capture knowledge within (and from
outside) the organization; offer solutions, improve processes and
deliverables through use of information; improves information
capital by contributing experience, deliverables, and models for
others to use.
Interpersonal Flexibility - ability to adapt to other personalities
in a respectful manner that is conducive to goal achievement.
Must be able to lead cross-functional and cross-regional teams and
deliver results in a matrix organization. Excellent organizational
skills and ability to prioritize.
Project Management abilities.
Must be strong communicator, and ability to explain complex
regulatory issues, trends, and strategies to a wide range of
Experience managing relationships with CROs and/or contractors a
In order to work at a Takeda site and to engage in-person with
other colleagues, customers and patients, either on-site or
off-site, you are required to provide proof that you are fully
vaccinated for COVID-19, absent an approved religious or medical
reason. At the start of your employment, or as soon as practicable
thereafter, you will be required to report your COVID-19
vaccination status. If you are unable to get vaccinated due to a
medical or religious reason and are seeking an accommodation, you
are required to complete the appropriate medical or religious
Takeda is proud in its commitment to creating a diverse workforce
and providing equal employment opportunities to all employees and
applicants for employment without regard to race, color, religion,
sex, sexual orientation, gender identity, gender expression,
parental status, national origin, age, disability, citizenship
status, genetic information or characteristics, marital status,
status as a Vietnam era veteran, special disabled veteran, or other
protected veteran in accordance with applicable federal, state and
local laws, and any other characteristic protected by law.
Massachusetts - Virtual
Keywords: Takeda Pharmaceutical, Newark , Associate Director - Labeling Quality - REMOTE, Executive , Newark, New Jersey
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