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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Associate Director, Clinical Packaging

Primary North Chicago, Illinois Req ID 2212436 Category Research and Development Division AbbVie

Purpose:
The Clinical Packaging Manager leads a site-specific production operation and manages and supervises the staff and facilities responsible for the packaging and labeling of materials. Although the managerial responsibility is at the local level, the incumbent is responsible and accountable for establishing and maintaining globally harmonized business and GMP processes and systems and for ensuring that his/her operation delivers materials in compliance with worldwide GMP regulations. Due to the need that accurate and timely delivery of clinical supplies is fundamental to successful clinical drug development, the head of this area is required to target 100% delivery performance without compromise to cost or quality.

Responsibilities:

  • Responsible for ~3 director reports and ~25 indirect reports. Manage workload fluctuations through contractor support. An additional 10-15 contractors are typically required to manage the workload. Manage and supervise staff to ensure that supplies are packaged and labeled within agreed timelines to ensure that all clinical studies start on time with no patient dosing interruptions.
  • Provide engineering support across clinical supply functions by managing internal and external engineering resource to meet the department needs. Responsible for developing and managing the data integrity strategy across the department.
  • Responsible for integration of new products from internal pipeline and business acquisitions/collaborations. Must ensure the area has the ability to package and label these new products which may require new equipment, packaging processes, and/or facility changes.
  • First line speaker in audits/inspections. Must maintain the area in a constant state of compliance. Accountable for compliance with global clinical GMP and regulatory regulations and requirements.
  • Ensure these highly manual processes are mistake proofed and support ‘a right first time’ mindset due to the risks associated with the use of active, placebo and comparator products.
  • Provide packaging and labeling production input into the global demand plan to ensure that supply chain commitments can be met.
  • Translate the demand plan into an achievable production plan and detailed production schedule for packaging and labeling unit. Balance workload across sites with other site counterparts and provide input into global outsourcing plans to assure effective handling of peak workloads based on capacity, cost, study requirements and technical expertise / specialization.
  • Implement continuous process and performance improvement through the design of Lean business and GMP processes that drive operational excellence and minimize operating costs. Stay informed of industry developments and benchmark other industries to innovate new ways of accomplishing business objectives. Help identify and implement new packaging technologies for the Clinical Packaging area.
  • Oversee validation program and ensure compliance to global clinical regulatory requirements and expectations for equipment, utility, facility qualifications as well as cleaning and software validation. Ensure calibration, validation and preventative maintenance are conducted on time.
  • Responsible for the initiation and approval of Exception documents.
  • Develop tools to collect baseline and ongoing Key Performance metrics that measure and monitor the productivity and efficiency of Clinical Packaging area at all levels.

Basic:

  • Bachelor’s Degree or equivalent: Life or Physical Sciences, Business Administration, Math, Engineering or Operations Management preferred. Advanced Degree: MBA desirable or equivalent breadth of experience.
  • 10+ years of experience in Pharmaceutical Industry with 5+ years Managerial experience.
  • 5+ years supervisory experience in a manufacturing/packaging plant environment with 2+ years clinical supplies experience.
  • Must have understanding and experience in one or more of the following areas/roles: Understanding of the investigational material supply chain and appreciation of worldwide regulatory and quality requirements in a complex manufacturing environment with a global charter.
  • Experience in planning and forecasting. Demonstrated knowledge of project planning/management processes and methods, capacity-demand planning, production planning and scheduling and proven organizational skills.

Key critical skills:

  • Business approach/aptitude and ability to easily make decisions within a complex and continuously changing environment.
  • Adaptability and flexibility.
  • Excellent interpersonal, team and leadership competencies.
  • Ability to drive towards the highest levels of performance.
  • Solid negotiation skills and the ability to handle many conflicting priorities.
  • Continuous performance improvement mindset and the ability to lead and inspire change.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time
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