Associate Director, Neurotoxin NPI Product Quality

at  AbbVie

Education & Experience

• Bachelor’s Degree in relevant Life Science or other technical area required.
• Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
• Total combined years of experience. Minimum of 10+ in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceutical setting. Required regulatory inspection experience with direct interaction with regulatory inspectors.
• Direct plant experience in a pharmaceutical setting with a minimum of 7 years preferred.
• Knowledge and a comprehensive understanding of some biological and/or pharmaceuticals.
• A wide range of activities are undertaken from long term strategy development to short term crisis management.
• The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy Corporate, Divisional, Regional, and local objectives to effectively manage the action plans that will resolve the issues

SO, WHAT DO YOU NEED TO DO THIS ROLE?

Education & Experience

• Bachelor’s Degree in relevant Life Science or other technical area required.
• Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
• Total combined years of experience. Minimum of 10+ in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceutical setting. Required regulatory inspection experience with direct interaction with regulatory inspectors.
• Direct plant experience in a pharmaceutical setting with a minimum of 7 years preferred.
• Knowledge and a comprehensive understanding of some biological and/or pharmaceuticals.
• A wide range of activities are undertaken from long term strategy development to short term crisis management.
• The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy Corporate, Divisional, Regional, and local objectives to effectively manage the action plans that will resolve the issues.

A snapshot of your key responsibilities as Associate Director, Neurotoxin NPI Product Quality would be:

• Represent Quality during product transfer activities with direct cross-functional team members to achieve on-time quality deliverables and high customer value.
• Ensures delivery of all quality elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centres, or to AbbVie domestic and International plants for further packaging and/or testing.
• Act as the primary quality representative for the global supply chain pertaining to manufacturing business relationships and build and maintain relationships with IME Operations, Supplier Quality Management, Commercial QA, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and S&T to ensure alignment on strategic initiatives.
• Develops Global Product Quality Assurance strategies and implements agreed strategies to support relevant products produced at AbbVie plants.
• Reviews, approves and opens necessary Quality System Management records in a timely manner to maintain a high level of product compliance. Supports the management of exception documents and CAPA.
• Makes key decisions on product quality, compliance and regulatory conformance issues and elevates medium and high-risk events to AbbVie management.
• Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the same agreements are being fulfilled.
• Core team member or lead of strategic NPI QA programs; including Brand Teams, New Product Introductions, Product Transfers and Global Strategic Initiatives.
• Influences the decision-making process to ensure quality requirements are included when improvement initiatives take place