The Labeling Operations Manager is responsible for overseeing the Supply Labeling Operations organization, providing oversight and leadership within the organization in support of supply to the US and /global markets. This position interfaces with internal functional groups (QA, Supply Planning, Supply Operations-CMO management, Regulatory Affairs, Visual Communications, Marketing) as well as Takeda business partners, and third-party vendors (print vendors, CMO drug product packagers) during the development and approval process for commercial product labeling to ensure common understanding of and execution of business objectives for labeling programs.
- Defines and implements compliant processes for managing labeling activities in support of Takeda Boston (TBOS) supply to global markets while ensuring effective integration into established global Takeda as well as local 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 TBOS and partners outside of the US (e.g., global artwork centers, market country RA and strategic business partners) 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.
- Creates artwork for new products / launches (clarification of specific branding and regulatory requirements on introduction of new products e.g. serial labeling, registered printing, etc); Work with the TBOS visual communications team, Takeda business partners as well as global regulatory representatives to provide clarification of regulatory and technical artwork requirements for applicable markets.
- Oversees vendor performance through management of labeling change projects, product launches, and by attending occasional site visits and supplier audits as required.
- Ensures timely creation of artwork mock-ups for all markets in support of regulatory submission to the authorities.
- Provide review and approval of ongoing artwork revision workflows within EQMS/EAMS systems; verification and sign-off of printed packaging materials in packaging masters to ensure usage of the correct pack mats.
- Ensures timely and reliable creation, and maintenance of printed product labeling artwork and ancillary supporting documentation (e.g., specifications, drawings) for all markets according to general specifications (Takeda branding guidelines, technical contours, templates, corporate design/marketing, Braille, printing techniques etc), 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.
- Identifies and implements continuous improvement opportunities.
- Creates, revises and approves GMP compliant SOP s to align with new and established policies and procedures.
- Oversee and direct proofreading activities in support of labeling projects; provides backup support to direct reports, peers and management as required .
- Additional duties as assigned.
EDUCATION, EXPERIENCE AND SKILLS:
- Associate s Degree required, Bachelor s degree preferred.
- 6 years of 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 Macintosh platform and of graphic software such as Adobe Creative Cloud (CC).
- 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.
- Excellent interpersonal skills; ability to work well independently as well as in a team environment.
- Management experience strongly preferred.
- Be 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 CMO packaging 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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