Associate Director - Labeling Quality- REMOTE
Company: Takeda Pharmaceutical
Location: Jersey City
Posted on: May 10, 2022
Job Description:
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in my employment application is true to the best of my
knowledge.Job DescriptionOBJECTIVES/PURPOSE
- 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 Affairs.
- 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
processes.
- 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.Leadership/People:No. of direct
reports: 0-1No. of indirect reports: 0-2ACCOUNTABILITIES
- Collaborates with Global Labeling leadership to ensure clear
and timely communication about labeling quality activities and
metrics.
- Responsible for alignment with global strategic initiatives
related to labeling events and the processes and systems used to
manage labeling quality.
- 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
quality documents).
- 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
labeling.
- 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 and practices
- Familiarity with inspections and audit procedures
- Excellent analytical, technical, and problemsolving skills (TQM
or Six Sigma experience preferred
- Project management abilitiesLeadership (Vision, strategy and
business alignment, people management, communication, influencing
others, managing change)
- Demonstrated ability to work across functions, regions and
cultures
- 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
comprehensible terms
- Embraces and demonstrates a diversity and inclusion mindset and
role models these behaviors for the organization
- Personnel management experienceDecision-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 simultaneouslyInteraction (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-wideInnovation (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
innovative solutions
- Ability to take risks implementing innovative solutions,
accelerating timelines throughout processesComplexity (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 complexityEDUCATION, BEHAVIOURAL COMPETENCIES
AND SKILLS: -
- Bachelor's degree (or equivalent) required. - Masters
preferred.
- 8+ years experience in Pharmaceutical or Medical Device
industry, with 5 years in Regulatory Affairs, labeling or quality
assurance/compliance.
- 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
stakeholders
- Experience managing relationships with CROs and/or contractors
a plus.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
accommodation form.EEO StatementTakeda 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.LocationsMassachusetts -
VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull
time
Keywords: Takeda Pharmaceutical, Jersey City , Associate Director - Labeling Quality- REMOTE, Executive , Jersey City, New Jersey
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