Director, Labeling Operations

Director, Labeling Operations

Baxter International

San Ġwann, Malta

Your role at Baxter

As a Director, Global Labeling Operations will provide leadership, innovation and technical expertise for the creation, maintenance and implementation for customer-facing technical documentation and product labeling for all products to meet company objectives and country-specific regulatory requirements.

Your team

• 50+ people with a mix of senior managers, matrixed teams, virtual teams, contractors, etc.
• Collaborative relationships with R&D, Marketing, Quality, Regulatory Affairs, Integrated Supply Chain (ISC) and other business functions.

What you'll be doing

• Set the strategic vision for Global Labeling organization to encourage global harmonization across functional areas and all countries.
• Owner of the Global Labeling process within the Global Quality Procedures (GQPs), accountable for the development, implementation, and continuous improvement of an effective process across the product portfolios, for all internal and external manufacturers.
• Responsible for all Baxter product labeling in all countries globally, including the New Product Introduction, Geographic Expansion and Sustaining portfolios for its business segments.
• Maintain awareness of global regulatory environments and assess impact of changes on Product Labeling activities.
• Leads key initiatives for process improvements, development of new tools, technologies to support efficient label development in support of submissions and product compliance.

What you'll bring

• Bachelor’s Degree or equivalent education (Master's Degree preferred).
• 12+ years of work experience in the Pharmaceutical and Medical Device industries preferred.
• Experience leading department Capital and Operating Expense budgets.
• Experience with implementing creative labeling strategies for both pharmaceuticals and medical device development programs.
• Understanding of FDA and EMA regulations and ICH guidelines, as well as comprehensive experience in the drug and medical device development process.

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Malta      Manufacturing and Logistics      Medical Devices      Pre-clinical Research and Development      Baxter International