Sr. Manager, Global Labeling Quality, Eu

Vor 6 Tagen

Zurich, Schweiz Takeda Pharmaceutical Vollzeit

The Senior Manager, GRA Labeling Quality, EU is responsible for 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 and Associate Directors of Global Labeling Quality, is responsible for successful labeling event management and tracking of global labeling updates.

Responsible for successful labeling event management and tracking of global labeling updates in the EU and Extended EU.

**ACCOUNTABILITIES**:

- Ensures clear and timely communication about labeling quality activities with stakeholders.
- Manages activities related to quality of labeling events and end-to-end tracking of labeling events
- Escalate issues/problems to management as needed
- Maintains strong knowledge of current regulations, legislation, best practices, and guidelines relating to Regulatory Affairs and labeling
- Supports evaluation and investigate of Quality Events, including conducting root cause analyses and develops corrective and prevention action plans
- Identifies and proposes process improvement opportunities and solutions
- Supports with other labeling operations activities as required
- Responsible for demonstrating Takeda leadership behaviors
- Drives compliance within the region to labeling event quality, labeling content, and adherence to KPIs and timeliness indicators.
- Presents on global and regional labeling processes and quality to inspectors and auditors
- Leads investigations into labeling quality events and ensure that corrective and preventative actions are appropriately identified and completed.
- Escalates issues/problems to Labeling Quality management as needed

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:

- Bachelor’s degree (or equivalent) required.Masters preferred.
- 5+ years experience in Pharmaceutical or Medical Device industry, with 3 years in Regulatory Affairs, labeling or quality assurance/compliance.
- Systems Knowledge -knowledge of Quality Management Systems, including EDMS, and Deviation (Trackwise) systems
- Regulatory Familiarity -awareness of European, US and international regulations relative to labeling
- Industry Knowledge -understanding of the medical device or 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.
- 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.

**Locations**:
Zurich, Switzerland

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time

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