Associate Director, Packaging Assurance

AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.

Plan and direct all standardization efforts and package development activities for AbbVie products worldwide, in addition to leading business process improvement efforts for the team. Responsible for package development, material testing and operations support for all products, and products manufactured for third parties. Provide technical and managerial leadership to various section managers, project managers, engineers, documentation editors, and serve on the packaging leadership team

Responsibilities:

• Lead multi-functional and diverse leadership team comprised of Quality Assurance, Supply Chain, R&D, Purchasing, and Science and Technology leaders within AbbVie. Responsible for packaging assurance, CAPA standards, packaging lab, and packaging management system. Will serve as a member of brand teams as well.
• Develop scope, design, cost estimate and implementation plans for major projects and lead multiple concurrent projects. Analyze plans to ensure that they are feasible within resource constraints. Review and adjust plans to meet overall business objectives. Define key results or objectives of project assignments and communicate roles and responsibilities to appropriate staff. Obtain resources (funding, staff, materials, equipment) necessary to complete key projects.
• Identify and implement cost reductions, own the departmental budget, and develop and handle the annual capital budget.
• Provide packaging engineering support to all AbbVie manufacturing plants. Provide first line of defense for packaging commodity quality issues experienced at the plants. Coordinate with Supplier Quality Assurance to address supplier quality problems
• Develop comprehensive contingency plans which address continued sources of supply of key packaging components; evaluate vulnerabilities related to materials, suppliers and their sites, molds, regulations and develop to limit risks to AbbVie.
• Provide support for the development and launch of new products. This includes defining package design parameters with Marketing and Product Development, developing and testing prototypes and authoring the CMC section of New Drug Applications (NDAs). Support Clinical operations in the development of new packaging systems that support administration and data collection for clinical drugs. Work closely with Pharmaceutical and Analytical Research and Development to evaluate programs.
• Possess a detailed understanding of all regulations and requirements associated with packaging and labeling. Ensure that all equipment in the Packaging test laboratory is validated and calibrated in accordance with regulatory requirements. Participate in internal and external audits of packaging. Represent AbbVie on FDA and Consumer Product Safety Commission audits.
• Develop material specifications and commodity drawings that are used by Corporate Purchasing to procure the packaging materials that are required to produce and ship AbbVie products. Develop and manage several databases used throughout AbbVie and within Packaging Engineering.
• Work very closely with suppliers and cultivate relationships with key commodity suppliers. Work with Corporate Purchasing to identify potential suppliers and play a significant role in supplier selection. Coordinate efforts of Packaging Engineering, Purchasing, Supplier Quality Assurance, Materials Management and Manufacturing to establish new suppliers.
• Lead team in evaluating new packaging or process technologies to enhance AbbVie packaging or increase productivity in production. Examples include: Bar codes, reduced space symbology codes and data matrix; anticounterfeit and product diversion technologies; material technologies such as switching from copolymer plastics to homopolymer plastics; molding technologies; induction sealing materials; preprinted foils; tamper-evident packaging.

• Bachelors Degree: Engineering or related discipline, or equivalent technical experience is required. Masters Degree/MBA preferred.
• Total combined minimum years of experience required is 10 years.
• Broad knowledge of health care packaging industry
• Possesses strong quality and regulatory understanding, quality management systems
• Proven leadership ability in driving business improvement and standardization.
• Excellent presentation skills with strong ability to articulate a vision
• Excellent interpersonal skills with the ability to lead, teach, and motivate individuals is required
• Highly detail oriented