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Associate Director - Labeling Quality - REMOTE

Company: Takeda Pharmaceutical
Location: Newark
Posted on: May 13, 2022

Job Description:

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Job Description
OBJECTIVES/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: 0-1
No. of indirect reports: 0-2

ACCOUNTABILITIES
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 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 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 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 innovative solutions
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 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 Statement
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.

Locations
Massachusetts - Virtual

Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time

Keywords: Takeda Pharmaceutical, Newark , Associate Director - Labeling Quality - REMOTE, Executive , Newark, New Jersey

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