Director, Global Labeling Quality, Eu
Vor 2 Tagen
Our team is growing and for this we need bright minds with creativity and flexibility - **what talent do you have?**
The Director, Global Labeling Quality, EU provides direction and leadership for activities related to labeling quality in the EU and Extended EU, including but not limited to inspection front room and response management.
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 matters related to global labeling quality.
Responsible for successful labeling event management and tracking of global labeling updates in the EU and Extended EU.
**ACCOUNTABILITIES**:
- Guide activities to provide a state of readiness for Health Authority inspections within Global Labeling and supporting local country (LOC) activities, including the development of strategic internal audit plans, and the execution of internal audits
- Evaluates and reviews compliance with Global Labeling procedures.
- Evaluate proposed commitments to Health Authorities in response to inspection findings for Global Labeling and LOC Labeling commitments
- Provide regulatory and technical expertise to manage the regulatory inspection preparation and execution processes, including development of any related tools and best practices
- Coordinates and collaborates with the training department to ensure delivery of role-based content.
- Works with cross-functional and regional teams to advance Global Labeling processes execution
- Communicate and escalate critical matters to leadership
- Supports post-marketing surveillance inspection and audit readiness and inspection and audit management activities
- Supports coordination of document requests and audit/ inspection interviews
- 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 but a masters is preferred.
- 7+ years’ experience from the pharmaceutical industry with at least 4 years of experience within labeling.
- Solid knowledge of EU regulations relative to labeling.
- Systems Knowledge -knowledge of Quality Management Systems, including EDMS, and Deviation (Trackwise) systems
- Industry Knowledge -understanding of the medical device or pharmaceutical industry and pharmaceutical companies’ operations processes and strategies including Regulatory Affairs processes.
- 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.
- Must be strong communicator, and ability to explain complex regulatory issues, trends, and strategies to a wide range of stakeholders
**Empowering our people to shine**
At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential.
As a global top employer, we offer exciting career paths, promote innovation, and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.
**Diversity, Equality, and Inclusion**
Takeda is committed to foster diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.
**Locations**:
Zurich, Switzerland
**Worker Type**:
Employee
**Worker Sub-Type**:
Regular
**Time Type**:
Full time
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