More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients' lives. If you are driven to create better health and a brighter future, join us! OBJECTIVES:
The Labeling Program Manager provides oversight and leadership within the Labeling Operations organization for strategic labeling initiatives in support of TPUSA supply to the US and /global markets. This position interfaces with partners within TPUSA and global Takeda organizations in order to ensure common understanding of and execution of business objectives for labeling programs. ACCOUNTABILITIES:
Qualifications EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Directs strategic labeling initiatives for TPUSA Labeling Operations in support of TPUSA manufacture for supply to US and global markets
- Defines and implements compliant processes for managing labeling activities in support of TPUSA supply to global markets while ensuring effective integration into established departmental processes
- Establishes communication plans for labeling related initiatives across functions and geographic areas
- Oversees staff of exempt and/or non-exempt personnel, directing resources in support of labeling development and implementation projects. Conducts performance reviews, provides, guidance, coaching, and provides development opportunities.
- Collaborates with Quality and Operations departments within TPUSA (e.g., Packaging and Engineering, Project Management) and partners outside of the US (e.g., global artwork centers, market country RA and business representatives) as well as third party CMOs and print suppliers, to achieve results.
- Evaluates unique labeling requirements and market requests to determine feasibility and identifies creative solutions based on print supplier and packager capabilities and limitations.
- Oversees vendor performance through management of labeling change projects, product launches, and by attending occasional site visits and supplier audits as required
- Ensures reliable creation, and maintenance of printed product labeling artwork and ancillary supporting documentation (e.g., specifications, drawings), ensuring copy and version integrity
- Identifies impact of new strategic initiatives (e.g., serialization, Braille, security features, tamper evidence, etc.) on labeling development and packaging operations
- Provides oversight and guidance to labeling project activities, directing resources and identifying resource needs to management
- Identifies and implements continuous improvement opportunities
- Modifies style guidelines for new labeling initiatives due to business model changes or emerging regulatory changes.
- Creates, revises and approves GMP compliant SOP's to align with new and established policies and procedures
- Provides backup support to peers and management, as required
- Oversee and direct proofreading activities in support of labeling projects
- Additional duties as assigned
- Bachelors degree or Associate's Degree required
- 7 years relevant Pharmaceutical Labeling, Packaging, and/or Quality work experience
- Expert knowledge of FDA regulations related to New Drug Applications, Good Manufacturing Practices, and Product Labeling
- Strong knowledge of print manufacturing processes and printing graphics techniques
- Strong knowledge of packaging processes and operations
- Flexibility to manage constantly shifting deadlines, varying deliverables, and communication complexities.
- Excellent communication skills, both oral and written
- High attention to detail
- Ability to work in a team environment
- Management experience preferred
- B e seated at a desk and perform text review (on paper or a computer screen) for up to 9 hours per day
- Occasional visits to third-party vendors such as pharmaceutical packagers or printing facilities
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires up to 20% travel
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